12 Corporate Governance jobs in Egypt
Senior Regulatory Affairs Specialist
New Cairo
IQVIA
Posted 4 days ago
Job Viewed
Job Description
We are hiring for a Senior Regulatory Role and are looking for an individual contributor who is proficient in regulatory knowledge and can work with a high sense of ownership under limited supervision. The role covers Egypt (experience in imported pharmaceutical and biological products), Libya, the GCC, and Jordan.
This role reports to the Regulatory Affairs Manager and is based in Egypt or Tunisia.
**Scope of Work**
+ Egypt, Libya, Jordan, and GCC regulatory experience is required.
+ Act as a Regional Regulatory Affairs Strategist on complex regulatory projects, developing and implementing country-level strategies in Egypt, Libya, Jordan, and the GCC.
+ Experience in both pharmaceuticals and biologicals is mandatory; medical device experience is a plus.
+ Experience with reliance regulations in Egypt and the GCC is essential.
**Responsibilities**
+ Prepare, review, and submit regulatory documentation (e.g., CTD and eCTD submissions); ensure follow-through on post-approval commitments.
+ Maintain product licenses in designated countries by overseeing all regulatory activities, including site registration and renewal, tender support, variations (CMC, labeling, MAT, administrative), product renewals, and withdrawals.
+ Review promotional materials for compliance with Health Authority (HA) requirements and ensure relevant HA approvals are obtained.
+ Possess good knowledge of pharmacovigilance requirements in relevant countries.
+ Engage with health authority officials as needed and represent the client.
+ Establish strong relationships with stakeholders, present regulatory projects and progress, and discuss issues and customer feedback.
+ Act as a subject matter expert in regulatory knowledge implementation for lifecycle maintenance, marketing authorization transfers, labeling, publishing, change assessments, and other relevant areas.
+ Stay updated with regulatory intelligence information from different health authorities, communicate insights to clients and working groups, and define the best strategies while anticipating future trends.
+ Understand the scope of work, deliverables, and management of budgets for several projects; manage workload appropriately.
+ Provide guidance to junior colleagues, including feedback on technical documents and assistance with their training, development, onboarding, and internships.
+ Perform other tasks or assignments as delegated by Regulatory Management.
**Qualifications**
+ Degree in life sciences or a related discipline is required; a professional postgraduate degree is a plus.
+ High proficiency in English and Arabic is essential; French proficiency is a plus.
+ At least 3-5 years of relevant regulatory experience in a national or regional scope of work.
+ Good understanding of regulations and related guidelines in the Gulf, Egypt, and Jordan.
+ Good understanding of pharmaceutical and biological regulations; medical device knowledge is a plus.
+ Familiarity with different regulatory dossiers (CTD, eCTD, NeeS) is a must.
+ Ability to read and understand high-level SOPs and e-trainings and to learn quickly within tight onboarding timelines.
+ Tech-savvy with proficiency in Veeva, digital workspace tools, publishing applications, Power BI, Task Planner, SharePoint, and other Microsoft Office tools; ability to collaborate effectively.
+ Knowledge of pharmaceutical industry operations.
+ Strong interpersonal communication and organizational skills.
+ Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
+ Demonstrates self-motivation, enthusiasm, and a high sense of ownership.
+ Organized with meticulous attention to detail to ensure accuracy in documentation and compliance.
If you believe you can bring adaptability to a rapidly changing environment, a problem-solving attitude, and a readiness to continuously upgrade your skills, please apply.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This role reports to the Regulatory Affairs Manager and is based in Egypt or Tunisia.
**Scope of Work**
+ Egypt, Libya, Jordan, and GCC regulatory experience is required.
+ Act as a Regional Regulatory Affairs Strategist on complex regulatory projects, developing and implementing country-level strategies in Egypt, Libya, Jordan, and the GCC.
+ Experience in both pharmaceuticals and biologicals is mandatory; medical device experience is a plus.
+ Experience with reliance regulations in Egypt and the GCC is essential.
**Responsibilities**
+ Prepare, review, and submit regulatory documentation (e.g., CTD and eCTD submissions); ensure follow-through on post-approval commitments.
+ Maintain product licenses in designated countries by overseeing all regulatory activities, including site registration and renewal, tender support, variations (CMC, labeling, MAT, administrative), product renewals, and withdrawals.
+ Review promotional materials for compliance with Health Authority (HA) requirements and ensure relevant HA approvals are obtained.
+ Possess good knowledge of pharmacovigilance requirements in relevant countries.
+ Engage with health authority officials as needed and represent the client.
+ Establish strong relationships with stakeholders, present regulatory projects and progress, and discuss issues and customer feedback.
+ Act as a subject matter expert in regulatory knowledge implementation for lifecycle maintenance, marketing authorization transfers, labeling, publishing, change assessments, and other relevant areas.
+ Stay updated with regulatory intelligence information from different health authorities, communicate insights to clients and working groups, and define the best strategies while anticipating future trends.
+ Understand the scope of work, deliverables, and management of budgets for several projects; manage workload appropriately.
+ Provide guidance to junior colleagues, including feedback on technical documents and assistance with their training, development, onboarding, and internships.
+ Perform other tasks or assignments as delegated by Regulatory Management.
**Qualifications**
+ Degree in life sciences or a related discipline is required; a professional postgraduate degree is a plus.
+ High proficiency in English and Arabic is essential; French proficiency is a plus.
+ At least 3-5 years of relevant regulatory experience in a national or regional scope of work.
+ Good understanding of regulations and related guidelines in the Gulf, Egypt, and Jordan.
+ Good understanding of pharmaceutical and biological regulations; medical device knowledge is a plus.
+ Familiarity with different regulatory dossiers (CTD, eCTD, NeeS) is a must.
+ Ability to read and understand high-level SOPs and e-trainings and to learn quickly within tight onboarding timelines.
+ Tech-savvy with proficiency in Veeva, digital workspace tools, publishing applications, Power BI, Task Planner, SharePoint, and other Microsoft Office tools; ability to collaborate effectively.
+ Knowledge of pharmaceutical industry operations.
+ Strong interpersonal communication and organizational skills.
+ Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
+ Demonstrates self-motivation, enthusiasm, and a high sense of ownership.
+ Organized with meticulous attention to detail to ensure accuracy in documentation and compliance.
If you believe you can bring adaptability to a rapidly changing environment, a problem-solving attitude, and a readiness to continuously upgrade your skills, please apply.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Supervisor - Pharmaceutical
Multicare Egypt for Pharmaceutical Industries
Posted today
Job Viewed
Job Description
**MultiCare** is a well-established Pharmaceutical Company with diversified scope in both manufacturing and marketing of pharmaceutical products, supplements, cosmetics and medical devices. **MultiCare** has +22 years of prominent existence in the local market and has almost +66 products marketed and more to come through the pipelines. **MultiCare **Egypt for Pharmaceutical Industries is the manufacturing facility is located at the Industrial Zone - New Cairo and its HQ at New Cairo as well. We are one of the fast growing Pharmaceutical Companies in the market which has strong ambition and aspiration to be one of the key players not only in Egypt but also within the region.
Our international alliances are effective in different countries, including Saudi Arabia, United Arab of Emirates, India and New Zealand with future aspiration to extend more business associations and affiliations in near future to further markets. Recently Multicare Poland has been launched which will be the entry port of the business to the European Union (EU).
Vacancy:
- Designation: Regulatory Affairs Supervisor
- Location: Industrial Zone, third Settlement, New Cairo
- Grade: RA01/RA02
- Reporting: Regulatory Affairs Manager
Job Purpose:
We are seeking a Regulatory Affairs Manager to provide support as we expand our product line. In this role, your primary responsibility is to oversee regulatory submissions, ensuring they are compliant with prevailing regulations as well as the guidelines set by other relevant regulatory bodies. You will also assist with external audits and respond to any complaint documentation regarding Multicare's portfolio
A. Essential Duties and Responsibilities:
- Contribute to the formulation and execution of regulatory strategies for Multicare's portfolio, proactively seeking innovative and rapid path to market. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the regulatory environment
- Act as one of the RA advisors on the applicable regulations that govern products in remit, provide guidance and considering all possible interpretations and regulatory pathway
- Provide Regulatory Affairs program governance, administration, business attestation review, metrics/reporting, and training
- Manage, maintain and communicate relevant policies, standards and procedures
- Communication with responsible regulatory authorities (national/international) as well as with notified bodies
- Ensure that a company's products comply with the regulations of the regions where they want to distribute them
- Provide support for all external audits Accountability, including audit corrective and preventive action plans (CAPAs).
- Collect, collate and evaluate scientific data from a range of sources
- Prepare submissions of license variations and renewals to strict deadlines
- Project manage teams of colleagues involved with the development of new products
- Negotiate with regulatory authorities for marketing authorization
- Take part in the development of marketing concepts and approve packaging and advertising before a product's release
- Act as the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of products
- Examine the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
- Enhance existing engagement model and serve as a trusted business partner representing the Regulatory Affairs organization to business functions, business lines, and other stakeholders
- Act as internal advisor on existing and emerging trends for products/categories in remit. Anticipate threats and opportunities. Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action
B.Qualification/Knowledge/Experience:
- Level of education: Life Science Degree (Pharmacy, Veterinary or Science)
- Experience: ≥ 3-5 years work experience in Regulatory Affairs function within pharmaceutical sector
- Language: English proficiency is mandated
- IT Literacy: Professional MS-Office knowledge
C. Competencies and Behaviors:
- Professional networking and MoH access
- Ability to work under sustainable pressure and handling of simultaneous tasks to meet timeline
- Strong planning and organization capabilities
- Ability to influence, convince and persuade
- Strong sense of accountability and autonomy
- Negotiation skills
- Must be flexible and adaptable to change
What we offer:
With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to l
Our international alliances are effective in different countries, including Saudi Arabia, United Arab of Emirates, India and New Zealand with future aspiration to extend more business associations and affiliations in near future to further markets. Recently Multicare Poland has been launched which will be the entry port of the business to the European Union (EU).
Vacancy:
- Designation: Regulatory Affairs Supervisor
- Location: Industrial Zone, third Settlement, New Cairo
- Grade: RA01/RA02
- Reporting: Regulatory Affairs Manager
Job Purpose:
We are seeking a Regulatory Affairs Manager to provide support as we expand our product line. In this role, your primary responsibility is to oversee regulatory submissions, ensuring they are compliant with prevailing regulations as well as the guidelines set by other relevant regulatory bodies. You will also assist with external audits and respond to any complaint documentation regarding Multicare's portfolio
A. Essential Duties and Responsibilities:
- Contribute to the formulation and execution of regulatory strategies for Multicare's portfolio, proactively seeking innovative and rapid path to market. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the regulatory environment
- Act as one of the RA advisors on the applicable regulations that govern products in remit, provide guidance and considering all possible interpretations and regulatory pathway
- Provide Regulatory Affairs program governance, administration, business attestation review, metrics/reporting, and training
- Manage, maintain and communicate relevant policies, standards and procedures
- Communication with responsible regulatory authorities (national/international) as well as with notified bodies
- Ensure that a company's products comply with the regulations of the regions where they want to distribute them
- Provide support for all external audits Accountability, including audit corrective and preventive action plans (CAPAs).
- Collect, collate and evaluate scientific data from a range of sources
- Prepare submissions of license variations and renewals to strict deadlines
- Project manage teams of colleagues involved with the development of new products
- Negotiate with regulatory authorities for marketing authorization
- Take part in the development of marketing concepts and approve packaging and advertising before a product's release
- Act as the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of products
- Examine the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
- Enhance existing engagement model and serve as a trusted business partner representing the Regulatory Affairs organization to business functions, business lines, and other stakeholders
- Act as internal advisor on existing and emerging trends for products/categories in remit. Anticipate threats and opportunities. Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action
B.Qualification/Knowledge/Experience:
- Level of education: Life Science Degree (Pharmacy, Veterinary or Science)
- Experience: ≥ 3-5 years work experience in Regulatory Affairs function within pharmaceutical sector
- Language: English proficiency is mandated
- IT Literacy: Professional MS-Office knowledge
C. Competencies and Behaviors:
- Professional networking and MoH access
- Ability to work under sustainable pressure and handling of simultaneous tasks to meet timeline
- Strong planning and organization capabilities
- Ability to influence, convince and persuade
- Strong sense of accountability and autonomy
- Negotiation skills
- Must be flexible and adaptable to change
What we offer:
With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to l
This advertiser has chosen not to accept applicants from your region.
1
Senior Regulatory Affairs Specialist
Flow Financial & Technology - Flow Talent
Posted 18 days ago
Job Viewed
Job Description
The Role
Overview
A leading pharmaceutical company is actively recruiting a Senior Regulatory Affairs Specialist for their Cairo office.
Please note that you must meet all the criteria set out below for your application to be considered. Suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion.
Responsibilities
- Maintenance of assigned, authorized products through timely submission of variations and renewal applications.
- Track and follow up with the submission of regulatory files (renewals, variations, etc.).
- Oversee post-marketing activities, including reporting adverse events and product quality complaints.
- Build and maintain strong relationships with regulatory bodies across the region.
- Prepare and review regulatory documents for accuracy and completeness.
- Work closely with R&D, quality assurance, supply chain, marketing, and legal departments to align regulatory strategies.
- Monitor and analyse regulatory trends in the MENA region.
Ideal Candidate Profile
- Only candidates currently based in Egypt will be considered.
- Bachelor's degree in Pharmacy, Life Sciences, or related field. An advanced degree (MBA, MSc) is a plus.
- Minimum 5 to 8 years of regulatory affairs experience within the pharmaceutical or healthcare industry.
- Experience in MENA-specific regulatory environments is a must.
- Strong understanding of regional and global regulatory standards.
- Detail-oriented with strong organizational and project management abilities.
This advertiser has chosen not to accept applicants from your region.
2
Regional Regulatory Affairs Strategist Manager
Pfizer
Posted today
Job Viewed
Job Description
Identifying Job Information_
JOB TITLE:
_Title reflected Pfizer Org Chart_)
Regional Regulatory Affairs strategist Manger
REPORTS TO:
_Manager Title_)
Regional Hub Team Lead
DIVISION/BUSINESS LINE:
Global Product Development (GPD)
VERSION DATE:
01-Feb-2019
SUB DIVISION:
Global Regulatory Affairs (GRA)
DEPARTMENT NAME:
Regional Regulatory Hub-AFME
LOCATION(S):
_indicate Pfizer locations_)
Africa Middle East
JOB INFORMATION
JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job.
- Manage projects and Handle related regulatory strategies for allocated Products, and ensure communication/clarity of regulatory timelines and strategy.
- Single point of contact for global/product strategists, and In-Country Regulatory Team on regional issues to facilitate the best in class support for product registration and product life cycle management activities.
- Responsible for ensuring that regulatory documentation meets relevant regulatory requirements.
- To ensure business continuity between global/product Strategists and In-Country Regulatory Team.
JOB RESPONSIBILITIES
Indicate the primary responsibilities critical to the job.
- Maintain knowledge base of country requirements and regulatory environment, Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
- Provide regional input to global regulatory strategy for the development of products in-line with business objectives, Assist and liaise with GCMC, global/product strategists, PGS, Submissions Management, In-Country Regulatory, ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
- Assist and support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
- Assist and oversee the preparation of regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
- Dispatch dossiers to In-Country Regulatory.
- Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that global/product strategists are aware of regulatory requirements (e.g., department presentations and Regulatory Requirements Database) Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
- Maintain Pfizer systems and databases, and applicable Pfizer policies and procedures.
- Responsible for ensuring product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
- Responsible for ensuring notifications of proposed regulatory changes are communicated to relevant stakeholders in a timely manner.
- Participate in-functional project teams in line with business needs, Responsible for ensuring that comprehensive records of country requirements (communication of requirements for RRM updates) and regulatory status, are maintained.
- To regularly follow up progress on regulatory submissions with In-Country Regulatory.
- Contributes to the development of filing and approval goals for the region.
- Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
- Appropriate Regulatory Experience : 4-6 years’ experience
- Proven ability to manage complex regulatory or drug development issues.
- Proven ability to consistently deliver to time, cost and quality standards.
- Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred
- Country/regional knowledge (For AfME only - specifically, MER, NEAR, South Africa, Maghreb)
- Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation.
- Knowledge of drug development practice, rules, regulations and guidelines.
- Technical skills with respect to understanding of CMC submissions, BoH Requirements to identify potential risks
- good communication, negotiation and interpersonal skills
- Strategic thinking
- Ability to manage complexity and negotiate skillfu
JOB TITLE:
_Title reflected Pfizer Org Chart_)
Regional Regulatory Affairs strategist Manger
REPORTS TO:
_Manager Title_)
Regional Hub Team Lead
DIVISION/BUSINESS LINE:
Global Product Development (GPD)
VERSION DATE:
01-Feb-2019
SUB DIVISION:
Global Regulatory Affairs (GRA)
DEPARTMENT NAME:
Regional Regulatory Hub-AFME
LOCATION(S):
_indicate Pfizer locations_)
Africa Middle East
JOB INFORMATION
JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job.
- Manage projects and Handle related regulatory strategies for allocated Products, and ensure communication/clarity of regulatory timelines and strategy.
- Single point of contact for global/product strategists, and In-Country Regulatory Team on regional issues to facilitate the best in class support for product registration and product life cycle management activities.
- Responsible for ensuring that regulatory documentation meets relevant regulatory requirements.
- To ensure business continuity between global/product Strategists and In-Country Regulatory Team.
JOB RESPONSIBILITIES
Indicate the primary responsibilities critical to the job.
- Maintain knowledge base of country requirements and regulatory environment, Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
- Provide regional input to global regulatory strategy for the development of products in-line with business objectives, Assist and liaise with GCMC, global/product strategists, PGS, Submissions Management, In-Country Regulatory, ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
- Assist and support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
- Assist and oversee the preparation of regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
- Dispatch dossiers to In-Country Regulatory.
- Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that global/product strategists are aware of regulatory requirements (e.g., department presentations and Regulatory Requirements Database) Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
- Maintain Pfizer systems and databases, and applicable Pfizer policies and procedures.
- Responsible for ensuring product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
- Responsible for ensuring notifications of proposed regulatory changes are communicated to relevant stakeholders in a timely manner.
- Participate in-functional project teams in line with business needs, Responsible for ensuring that comprehensive records of country requirements (communication of requirements for RRM updates) and regulatory status, are maintained.
- To regularly follow up progress on regulatory submissions with In-Country Regulatory.
- Contributes to the development of filing and approval goals for the region.
- Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
- Appropriate Regulatory Experience : 4-6 years’ experience
- Proven ability to manage complex regulatory or drug development issues.
- Proven ability to consistently deliver to time, cost and quality standards.
- Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred
- Country/regional knowledge (For AfME only - specifically, MER, NEAR, South Africa, Maghreb)
- Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation.
- Knowledge of drug development practice, rules, regulations and guidelines.
- Technical skills with respect to understanding of CMC submissions, BoH Requirements to identify potential risks
- good communication, negotiation and interpersonal skills
- Strategic thinking
- Ability to manage complexity and negotiate skillfu
This advertiser has chosen not to accept applicants from your region.
3
Regional Regulatory Affairs Strategist Manager
Pfizer
Posted today
Job Viewed
Job Description
Identifying Job Information_
JOB TITLE:
_Title reflected Pfizer Org Chart_)
Regional Regulatory Affairs strategist Manger
REPORTS TO:
_Manager Title_)
Regional Hub Team Lead
DIVISION/BUSINESS LINE:
Global Product Development (GPD)
VERSION DATE:
01-Feb-2019
SUB DIVISION:
Global Regulatory Affairs (GRA)
DEPARTMENT NAME:
Regional Regulatory Hub-AFME
LOCATION(S):
_indicate Pfizer locations_)
Africa Middle East
JOB INFORMATION
JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job.
- Manage projects and Handle related regulatory strategies for allocated Products, and ensure communication/clarity of regulatory timelines and strategy.
- Single point of contact for global/product strategists, and In-Country Regulatory Team on regional issues to facilitate the best in class support for product registration and product life cycle management activities.
- Responsible for ensuring that regulatory documentation meets relevant regulatory requirements.
- To ensure business continuity between global/product Strategists and In-Country Regulatory Team.
JOB RESPONSIBILITIES
Indicate the primary responsibilities critical to the job.
- Maintain knowledge base of country requirements and regulatory environment, Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
- Provide regional input to global regulatory strategy for the development of products in-line with business objectives, Assist and liaise with GCMC, global/product strategists, PGS, Submissions Management, In-Country Regulatory, ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
- Assist and support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
- Assist and oversee the preparation of regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
- Dispatch dossiers to In-Country Regulatory.
- Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that global/product strategists are aware of regulatory requirements (e.g., department presentations and Regulatory Requirements Database) Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
- Maintain Pfizer systems and databases, and applicable Pfizer policies and procedures.
- Responsible for ensuring product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
- Responsible for ensuring notifications of proposed regulatory changes are communicated to relevant stakeholders in a timely manner.
- Participate in-functional project teams in line with business needs, Responsible for ensuring that comprehensive records of country requirements (communication of requirements for RRM updates) and regulatory status, are maintained.
- To regularly follow up progress on regulatory submissions with In-Country Regulatory.
- Contributes to the development of filing and approval goals for the region.
- Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
- Appropriate Regulatory Experience : 4-6 years’ experience
- Proven ability to manage complex regulatory or drug development issues.
- Proven ability to consistently deliver to time, cost and quality standards.
- Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred
- Country/regional knowledge (For AfME only - specifically, MER, NEAR, South Africa, Maghreb)
- Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation.
- Knowledge of drug development practice, rules, regulations and guidelines.
- Technical skills with respect to understanding of CMC submissions, BoH Requirements to identify potential risks
- good communication, negotiation and interpersonal skills
- Strategic thinking
- Ability to manage complexity and negotiate skillfu
JOB TITLE:
_Title reflected Pfizer Org Chart_)
Regional Regulatory Affairs strategist Manger
REPORTS TO:
_Manager Title_)
Regional Hub Team Lead
DIVISION/BUSINESS LINE:
Global Product Development (GPD)
VERSION DATE:
01-Feb-2019
SUB DIVISION:
Global Regulatory Affairs (GRA)
DEPARTMENT NAME:
Regional Regulatory Hub-AFME
LOCATION(S):
_indicate Pfizer locations_)
Africa Middle East
JOB INFORMATION
JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job.
- Manage projects and Handle related regulatory strategies for allocated Products, and ensure communication/clarity of regulatory timelines and strategy.
- Single point of contact for global/product strategists, and In-Country Regulatory Team on regional issues to facilitate the best in class support for product registration and product life cycle management activities.
- Responsible for ensuring that regulatory documentation meets relevant regulatory requirements.
- To ensure business continuity between global/product Strategists and In-Country Regulatory Team.
JOB RESPONSIBILITIES
Indicate the primary responsibilities critical to the job.
- Maintain knowledge base of country requirements and regulatory environment, Maintain effective regional relationship with stakeholders to ensure communication /clarity of regulatory strategy and timelines.
- Provide regional input to global regulatory strategy for the development of products in-line with business objectives, Assist and liaise with GCMC, global/product strategists, PGS, Submissions Management, In-Country Regulatory, ILG, ALIM, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and BoH requirements are met, ensuring a submission ready dossier. Ensure that the appropriate regulatory requirements systems and database are updated in a timely manner when changes occur in market regulations. Ensure a submission planning and forecasting tool is utilized to update timelines.
- Assist and support all product lifecycle regulatory work, and liaise with GCMC, Submissions Management, Cluster/Market, and any other key stakeholders.
- Assist and oversee the preparation of regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
- Dispatch dossiers to In-Country Regulatory.
- Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and ensure that global/product strategists are aware of regulatory requirements (e.g., department presentations and Regulatory Requirements Database) Regularly follow up with In-Country Regulatory Team on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings.
- Maintain Pfizer systems and databases, and applicable Pfizer policies and procedures.
- Responsible for ensuring product strategies, submission and approval time lines, and country registration requirements/guidelines are accurately captured and current in applicable systems/regulatory databases.
- Responsible for ensuring notifications of proposed regulatory changes are communicated to relevant stakeholders in a timely manner.
- Participate in-functional project teams in line with business needs, Responsible for ensuring that comprehensive records of country requirements (communication of requirements for RRM updates) and regulatory status, are maintained.
- To regularly follow up progress on regulatory submissions with In-Country Regulatory.
- Contributes to the development of filing and approval goals for the region.
- Ensure systems are in place and adhered to, to optimize process efficiency with out-sourced and in-house contractors, where applicable.
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- Scientific Degree. A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
- Appropriate Regulatory Experience : 4-6 years’ experience
- Proven ability to manage complex regulatory or drug development issues.
- Proven ability to consistently deliver to time, cost and quality standards.
- Attitude: Right mindset, Outward looking, Strategically minded, Project management skills preferred
- Country/regional knowledge (For AfME only - specifically, MER, NEAR, South Africa, Maghreb)
- Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation.
- Knowledge of drug development practice, rules, regulations and guidelines.
- Technical skills with respect to understanding of CMC submissions, BoH Requirements to identify potential risks
- good communication, negotiation and interpersonal skills
- Strategic thinking
- Ability to manage complexity and negotiate skillfu
This advertiser has chosen not to accept applicants from your region.
4
Sr Associate Regulatory Affairs - based in Egypt
Cairo, Al Qahirah
Amgen
Posted 23 days ago
Job Viewed
Job Description
**HOW MIGHT YOU DEFY IMAGINATION?**
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
**Sr Associate Regulatory Affairs - based in Egypt**
**Live**
**What you will do**
Let's do this. Let's change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance :
+ Ensures regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements
+ With close supervision, implements the filing plan (MA and Lifecycle maintenance) for their countries, where applicable
+ Reviews promotional and non-promotional materials
+ Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner
+ Partners with Regulatory Affairs Lead to support the regulatory development, registration, and lifecycle management of all Amgen molecules
+ Partners with peers to ensure consistency on procedures
+ Assists locally in Healthcare Compliance activities, where applicable
+ Participates in local regulatory process improvements, initiatives, and training
+ Establishes regular contacts and interactions with Distributors (if applicable).
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Sr Regulatory Affairs professional we seek is a teammate with these qualifications.
**Basic Qualifications:**
+ Bachelor`s degree in Pharmaceutical Science
+ Knowledge of the Gulf legislation and regulations
+ Awareness of the registration procedures in region, post approval changes, extensions and renewals
+ Knowledge of Regulatory principles
+ Working with policies, procedures and SOP's
+ Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
+ Understanding of drug development
+ Demonstrate ability to work in teams
+ Ability to understand and communicate scientific/clinical information
**Preferred Qualifications:**
+ Degree and in-depth regulatory experience of the Gulf Markets (1-2 years experience)
+ Depth knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.
+ Experience interacting with regulatory agency in the Gulf markets
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
**Sr Associate Regulatory Affairs - based in Egypt**
**Live**
**What you will do**
Let's do this. Let's change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance :
+ Ensures regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements
+ With close supervision, implements the filing plan (MA and Lifecycle maintenance) for their countries, where applicable
+ Reviews promotional and non-promotional materials
+ Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner
+ Partners with Regulatory Affairs Lead to support the regulatory development, registration, and lifecycle management of all Amgen molecules
+ Partners with peers to ensure consistency on procedures
+ Assists locally in Healthcare Compliance activities, where applicable
+ Participates in local regulatory process improvements, initiatives, and training
+ Establishes regular contacts and interactions with Distributors (if applicable).
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Sr Regulatory Affairs professional we seek is a teammate with these qualifications.
**Basic Qualifications:**
+ Bachelor`s degree in Pharmaceutical Science
+ Knowledge of the Gulf legislation and regulations
+ Awareness of the registration procedures in region, post approval changes, extensions and renewals
+ Knowledge of Regulatory principles
+ Working with policies, procedures and SOP's
+ Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
+ Understanding of drug development
+ Demonstrate ability to work in teams
+ Ability to understand and communicate scientific/clinical information
**Preferred Qualifications:**
+ Degree and in-depth regulatory experience of the Gulf Markets (1-2 years experience)
+ Depth knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.
+ Experience interacting with regulatory agency in the Gulf markets
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
This advertiser has chosen not to accept applicants from your region.
5
Legal Counsel
Heineken
Posted today
Job Viewed
Job Description
At ABC, we brew the joy of true togetherness to inspire a better world. A big part of that means brewing better people with the heart of our company in our four values:
- **Passion for consumers and customers**:
- **Care for people and planet**:
- **Enjoyment of life**:
- **Courage to dream and pioneer**
**Job Purpose**
**Duties and Responsibilities**:
- **Contracts**:
- Negotiate, review and draft all types of agreements for the different departments such as (commercial, HR, Finance, Operational etc.). Hold required internal & external meetings with stakeholders to negotiate terms of agreements.
- Ensuring the update of the templates with any new requirements to be added or removed, according to company policies, laws and regulations.
- Maintaining and updating a shared database for all contracts to ensure smooth accessibility to templates.
- Ensure that the legal function has the originals of all agreements and legal documents
- Manage the archiving system of contracts to ensure proper physical and soft location of contracts
- **Litigation**
- Follow up with the external lawyers on the court cases and maintaining a record for hearing dates.
- Follow-up on the litigation reports by the law firm and written pleadings and preparation of documents
- Ensure proper communication to the relevant department on the progress of the cases
- **Compliance and Legal Operation**
- Conduct legal research and provide legal opinions to all ABC departments.
- Provide legal advice and opinions in all legal aspects, in addition to interpreting legislation, rulings and regulations
- Ensure the company operation, daily practice and internal documents are in line with legal requirements and especially competition law and company’s policies.
- Provide legal trainings to ABC business departments and raise legal awareness per function
- Assist the Senior Legal Counsel in strategic pillars such as (IP, License to Operate and Corporate Governance).
- Act as the compliance officer for their concerned departments
- Handle other administrative and corporate tasks including but not limited to in preparing presentation materials, drafting minutes for meetings, OGMs, etc, depending on the business.
**Education & Experiences**
**Educational Background**:Bachelor’s degree in Law
**Years of Experience**: 1-3 years of relevant experience preferably in FMCGs. Previous experience in Legal Department of an international cooperation or international cooperation or multinational Law firm.
**Qualifications & Other Requirements**
- Excellent command of English and Arabic Languages
- Excellent Microsoft Office knowledge especially Outlook and PowerPoint
- Excellent legal skills and knowledge of Egyptian Laws
- Keep up to date on relevant changes in laws
**Personal Skills**
- Critical and Challenging
- Analytical Skills
- Confident in communicating at all levels of seniority
- High Persuasion and Negotiation skills
- Pro-active & Teamwork oriented
**Functional Competencies**:
**Agile Mindset**
Curious and wants to learn.
Not afraid to propose and try new things; is prepared to fail, learn and share.
Can change and adapt quickly; embraces change. Actively seeks opportunities to improve processes and procedures.
**Digitally.Adept**
Understands the digital strategy of HEINEKEN and provides expert legal advice.
Identifies legal issues in digital projects.
Completes appropriate digital legal skills training. Advocates use of new technology to improve legal services; actively seeks ways to further use of technology; gathers, interprets and analyses data to make insight-driven recommendations and decisions.
**Legal Expertise**
Consistently demonstrates practical and strategic legal expertise; gives timely advice; works with pace and urgency.
Takes pride in the quality of own work.
Actively shares knowledge and trains others; helps to create a continuous learning environment. Actively develops oneself and own skills.
**Professional Judgement**
Has detailed knowledge of our business and the brewing industry.
Provides expert professional judgement and timely guidance to benefit the business.
Acts with integrity. Follows trends and takes all relevant factors into account in decisions.
Takes calculated risks, seeks guidance when needed.
Seeks views of others but makes own independent judgements.
Applies business acumen; weighs commercial interests and business risks
Applies knowledge to benefit the business.
**Problem Solving**
Is practical, creative and thinks outside the box.
Manages problems, challenges and issues effectively and on time.
Asks oneself “how can I make this work?”; proposes and implements solutions. Reaches out for help when needed.
**Stakeholder Management**
Communicates legal issues in a concise, clear and fact-based manner.
Earns trust by building solid and sustainable internal and external relationships.
Takes responsibility and accountability for own work and legal issues. Interacts with stakeholders with pro
- **Passion for consumers and customers**:
- **Care for people and planet**:
- **Enjoyment of life**:
- **Courage to dream and pioneer**
**Job Purpose**
**Duties and Responsibilities**:
- **Contracts**:
- Negotiate, review and draft all types of agreements for the different departments such as (commercial, HR, Finance, Operational etc.). Hold required internal & external meetings with stakeholders to negotiate terms of agreements.
- Ensuring the update of the templates with any new requirements to be added or removed, according to company policies, laws and regulations.
- Maintaining and updating a shared database for all contracts to ensure smooth accessibility to templates.
- Ensure that the legal function has the originals of all agreements and legal documents
- Manage the archiving system of contracts to ensure proper physical and soft location of contracts
- **Litigation**
- Follow up with the external lawyers on the court cases and maintaining a record for hearing dates.
- Follow-up on the litigation reports by the law firm and written pleadings and preparation of documents
- Ensure proper communication to the relevant department on the progress of the cases
- **Compliance and Legal Operation**
- Conduct legal research and provide legal opinions to all ABC departments.
- Provide legal advice and opinions in all legal aspects, in addition to interpreting legislation, rulings and regulations
- Ensure the company operation, daily practice and internal documents are in line with legal requirements and especially competition law and company’s policies.
- Provide legal trainings to ABC business departments and raise legal awareness per function
- Assist the Senior Legal Counsel in strategic pillars such as (IP, License to Operate and Corporate Governance).
- Act as the compliance officer for their concerned departments
- Handle other administrative and corporate tasks including but not limited to in preparing presentation materials, drafting minutes for meetings, OGMs, etc, depending on the business.
**Education & Experiences**
**Educational Background**:Bachelor’s degree in Law
**Years of Experience**: 1-3 years of relevant experience preferably in FMCGs. Previous experience in Legal Department of an international cooperation or international cooperation or multinational Law firm.
**Qualifications & Other Requirements**
- Excellent command of English and Arabic Languages
- Excellent Microsoft Office knowledge especially Outlook and PowerPoint
- Excellent legal skills and knowledge of Egyptian Laws
- Keep up to date on relevant changes in laws
**Personal Skills**
- Critical and Challenging
- Analytical Skills
- Confident in communicating at all levels of seniority
- High Persuasion and Negotiation skills
- Pro-active & Teamwork oriented
**Functional Competencies**:
**Agile Mindset**
Curious and wants to learn.
Not afraid to propose and try new things; is prepared to fail, learn and share.
Can change and adapt quickly; embraces change. Actively seeks opportunities to improve processes and procedures.
**Digitally.Adept**
Understands the digital strategy of HEINEKEN and provides expert legal advice.
Identifies legal issues in digital projects.
Completes appropriate digital legal skills training. Advocates use of new technology to improve legal services; actively seeks ways to further use of technology; gathers, interprets and analyses data to make insight-driven recommendations and decisions.
**Legal Expertise**
Consistently demonstrates practical and strategic legal expertise; gives timely advice; works with pace and urgency.
Takes pride in the quality of own work.
Actively shares knowledge and trains others; helps to create a continuous learning environment. Actively develops oneself and own skills.
**Professional Judgement**
Has detailed knowledge of our business and the brewing industry.
Provides expert professional judgement and timely guidance to benefit the business.
Acts with integrity. Follows trends and takes all relevant factors into account in decisions.
Takes calculated risks, seeks guidance when needed.
Seeks views of others but makes own independent judgements.
Applies business acumen; weighs commercial interests and business risks
Applies knowledge to benefit the business.
**Problem Solving**
Is practical, creative and thinks outside the box.
Manages problems, challenges and issues effectively and on time.
Asks oneself “how can I make this work?”; proposes and implements solutions. Reaches out for help when needed.
**Stakeholder Management**
Communicates legal issues in a concise, clear and fact-based manner.
Earns trust by building solid and sustainable internal and external relationships.
Takes responsibility and accountability for own work and legal issues. Interacts with stakeholders with pro
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Corporate governance Jobs in Egypt !
6
Head of Audit, Control and Risk Management
Orange
Posted today
Job Viewed
Job Description
**Purpose of the job**
Lead the Internal Audit (operations and IT), BCM governance and Internal Control SOX Compliance in Orange and LDN to ensure full compliance with internal policies and controls as well Orange Group requirements and International Standards in this domain.
**Duties and responsibilities**
- Set directions to be followed in the annually developed Internal Audit, BCM, and Internal Control SOX Compliance plans and business objectives for the function while ensuring alignment with department and company strategy and risk.
- Prepare the annual Internal Audit, and Internal Control SOX Compliance based on risk assessment, business needs and other relevant factors.
- Follow-up on the implementation of the annual Internal Audit, and Internal Control SOX Compliance plan.
- Develop functions annual budget and control expenses.
- Monitor the teams field work and follow up on activities.
- Coordinate follow-up activities to overcome weaknesses highlighted by external auditors and Orange Group Audit and Control bodies in their reports.
- Coordinate follow-up activities on all open action plans by management for weaknesses raised by the Internal Audit Department.
- Prepare/review and issue audit / ad-hoc reports and propose recommendations on observed findings.
- Review the SOX Assessment of the control environment work streams and the Financial Reporting and Closing process, and prepare the yearly SOX Attestation Letter.
- Update work methodology according to evolving work challenges and company needs.
- Provide the Audit committee and the board of directors with a half-yearly report representing Internal Audit Department performance.
- Present to the CEO and Executive Committee the results of the Internal Audit Department work and weaknesses identified.
- Enhance the functions performance by introducing new software / tools to increase the efficiency and improve quality of work.
- Ensure adherence to Oranges procedures and regulations.
- People management:
- Interview and select direct reports and validate hiring decisions for the function.
- Conduct regular performance and competency evaluations for direct reports while delivering constant constructive feedback for higher achievements and further development.
- Provide coaching and request needed training for direct reports ensuring continuous individual development.
- Ensure a healthy working environment for the functions employees through focusing on team building and motivation initiatives.
**Job specification**
**Education**
- University degree in Accounting.
- International Certification in auditing is an asset.
**Experience**
- Minimum 10 years of experience in Finance and Auditing, 5 of which in a managerial position.
**Skills and abilities**
- Very good English both spoken and written.
- Very good computer skills.
- Very good communication skills.
- Detail and quality oriented.
- Strong investigative and reporting skills.
- Strong people management skills.
**contract**:
Regular
Lead the Internal Audit (operations and IT), BCM governance and Internal Control SOX Compliance in Orange and LDN to ensure full compliance with internal policies and controls as well Orange Group requirements and International Standards in this domain.
**Duties and responsibilities**
- Set directions to be followed in the annually developed Internal Audit, BCM, and Internal Control SOX Compliance plans and business objectives for the function while ensuring alignment with department and company strategy and risk.
- Prepare the annual Internal Audit, and Internal Control SOX Compliance based on risk assessment, business needs and other relevant factors.
- Follow-up on the implementation of the annual Internal Audit, and Internal Control SOX Compliance plan.
- Develop functions annual budget and control expenses.
- Monitor the teams field work and follow up on activities.
- Coordinate follow-up activities to overcome weaknesses highlighted by external auditors and Orange Group Audit and Control bodies in their reports.
- Coordinate follow-up activities on all open action plans by management for weaknesses raised by the Internal Audit Department.
- Prepare/review and issue audit / ad-hoc reports and propose recommendations on observed findings.
- Review the SOX Assessment of the control environment work streams and the Financial Reporting and Closing process, and prepare the yearly SOX Attestation Letter.
- Update work methodology according to evolving work challenges and company needs.
- Provide the Audit committee and the board of directors with a half-yearly report representing Internal Audit Department performance.
- Present to the CEO and Executive Committee the results of the Internal Audit Department work and weaknesses identified.
- Enhance the functions performance by introducing new software / tools to increase the efficiency and improve quality of work.
- Ensure adherence to Oranges procedures and regulations.
- People management:
- Interview and select direct reports and validate hiring decisions for the function.
- Conduct regular performance and competency evaluations for direct reports while delivering constant constructive feedback for higher achievements and further development.
- Provide coaching and request needed training for direct reports ensuring continuous individual development.
- Ensure a healthy working environment for the functions employees through focusing on team building and motivation initiatives.
**Job specification**
**Education**
- University degree in Accounting.
- International Certification in auditing is an asset.
**Experience**
- Minimum 10 years of experience in Finance and Auditing, 5 of which in a managerial position.
**Skills and abilities**
- Very good English both spoken and written.
- Very good computer skills.
- Very good communication skills.
- Detail and quality oriented.
- Strong investigative and reporting skills.
- Strong people management skills.
**contract**:
Regular
This advertiser has chosen not to accept applicants from your region.
7
MESA Senior Legal Counsel
GE HealthCare
Posted 13 days ago
Job Viewed
Job Description
**Job Description Summary**
Lawyers supporting the commercial side of the business including contract development and agreement management, external customer sales of products and services, government contracting. Interprets strategic internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
**Job Description**
**Roles and Responsibilities**
+ Lawyers providing legal leadership and oversight to business operations. Includes, but is not limited to, strategic support of business growth goals, supporting strategic/complex transactions, government contracts/public tenders, standard/flow commercial transactions, healthcare regulatory advice and counsel, and management of investigations, litigation and customer disputes.
+ The role provides strategic support for legal in the Middle East countries and Saudi Arabia. The role reports to the Executive General Counsel in EAGM Zone and supports the Leadership Team in Middle East and Saudi Arabia (MESA).
+ Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness, and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation.
+ May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on particular topics. May guide others to consider a different point of view.
+ Impacts the team's ability to achieve service, quality and timeliness of objectives. Work is subject to functional policy objectives. Regularly advises management in the function and/or in the business. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.
+ Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
**Required Qualifications**
+ This role requires significant experience in the Legal & Business Counsel.
+ Has experience in the legal support for the Middle East and Saudi Arabia for at least 10 years.
+ Arabic speaking
**Desired Characteristics**
+ Strong oral and written communication skills. Strong interpersonal and leadership skills.
+ Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects.
+ Ability to document, plan, market, and execute programs.
**Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-FG1
#LI-Hybrid
**Additional Information**
**Relocation Assistance Provided:** No
Lawyers supporting the commercial side of the business including contract development and agreement management, external customer sales of products and services, government contracting. Interprets strategic internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
**Job Description**
**Roles and Responsibilities**
+ Lawyers providing legal leadership and oversight to business operations. Includes, but is not limited to, strategic support of business growth goals, supporting strategic/complex transactions, government contracts/public tenders, standard/flow commercial transactions, healthcare regulatory advice and counsel, and management of investigations, litigation and customer disputes.
+ The role provides strategic support for legal in the Middle East countries and Saudi Arabia. The role reports to the Executive General Counsel in EAGM Zone and supports the Leadership Team in Middle East and Saudi Arabia (MESA).
+ Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness, and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation.
+ May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on particular topics. May guide others to consider a different point of view.
+ Impacts the team's ability to achieve service, quality and timeliness of objectives. Work is subject to functional policy objectives. Regularly advises management in the function and/or in the business. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.
+ Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
**Required Qualifications**
+ This role requires significant experience in the Legal & Business Counsel.
+ Has experience in the legal support for the Middle East and Saudi Arabia for at least 10 years.
+ Arabic speaking
**Desired Characteristics**
+ Strong oral and written communication skills. Strong interpersonal and leadership skills.
+ Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects.
+ Ability to document, plan, market, and execute programs.
**Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-FG1
#LI-Hybrid
**Additional Information**
**Relocation Assistance Provided:** No
This advertiser has chosen not to accept applicants from your region.
8
Compliance Officer
Jamjoom pharma
Posted today
Job Viewed
Job Description
**Compliance Officer **based at Jamjoom Pharma Headquarters in Jeddah - Saudi Arabia.**
***Key Responsibilities**
As a** Compliance Officer**, you will be responsible for providing management and day to day support to the Company’s overall Compliance activities across all business units and functions ensuring that risks and controls from project inception to support within their business unit are identified, prioritized, effectively managed, and monitored. Additionally this role should work within the business unit to ensure Company follows the required internal and external compliance standards and delivers a reduction in the overall risk profile.
The primary responsibility of this position will be:
- Compliance (including Operations, Regulatory and Policy Framework)
- Corporate Governance Compliance
- Support Risk Management
- Management Monitoring
- Compliance Policy/SOPs Formation, lunch and monitoring
- Compliance Maintenance to Pharmaceutical Laws across the countries where the Company operates.
**Compliance **(including Operations, Regulatory and Policy Framework)**:
- Contribute to maintenance of the Business Unit delivery and operational frameworks (Activities, deliverables, roles, and responsibilities) and ensure alignment to country regulations.
- Ensure Company activities align with SFDA (and equivalent outside Saudi) Regulatory requirements and liaise with commercial/marketing to ensure proper implementation of the regulations.
- Contribute to ensuring the Company is keeping up to date with regulatory and legal requirements through a pro-active knowledge management program in alignment with legal function.
- Ensure the Company and all its BU and functions adhere to its Bylaws, charters. Policies and authority levels.
- Support tracking and managing all CAPAs across BU, department and functions and escalate to top management and audit committee any significant gaps and findings.
**Corporate Governance Compliance**
- Ensure that the Company complies and adheres to all required regulatory filling and keeps up-to-date corporate registry and official documents.
- Ensuring that policies and SOPs are in place to ensure proper management and tracking of regulatory filling and disclosures including capital market authority requirements.
**Risk Management**
- Contribute to identification and initiation of Risk mitigation projects to address significant risks impacting the Company
- Facilitate risk identification and risk discussions within BU, both operational risk, regulatory and strategic risk
- Assist the Management to make risk informed decisions through a comprehensive Risk Dashboard
- Raise and approve (where necessary) Policy Exceptions and significant Risks
- Input into, review and enforce compliance within Policies and Standards as required within Business Unit
- Ensure emerging risks are identified and escalated appropriately and in a timely manner
- Perform GRC requirements within third party framework
- Ensure awareness of process and report suspected breach
- Provide training and education program to ensure ongoing awareness on new and updated Policies and Standards within the Company
**Audit Support**
- Contribute to ensuring Business Unit is ready to host external inspections from regulatory bodies
- Support management of overall Business Unit inspection readiness activities and CAPAs in liaison with the business
- Report status on CAPA’s to Business Unit RMCB
**Policy Formation**
- Create, review, and approve policy, standards, procedures, guidance, and training for compliance with relevant legislation and SOP Requirements.
- Support reviews of the commercial and marketing activities to make sure it complies with legislation and specifies any required changes within their Business Unit
**Basic Qualifications**
- Bachelor’s Degree in Pharmaceutical, Accounting.
- Have 7:10 years’ experience in Compliance and Risk Management.
- Experience in Pharmaceutical industry.
- Certifications in IFSA, CCA.
- Fluent in English and Arabic.
***Key Responsibilities**
As a** Compliance Officer**, you will be responsible for providing management and day to day support to the Company’s overall Compliance activities across all business units and functions ensuring that risks and controls from project inception to support within their business unit are identified, prioritized, effectively managed, and monitored. Additionally this role should work within the business unit to ensure Company follows the required internal and external compliance standards and delivers a reduction in the overall risk profile.
The primary responsibility of this position will be:
- Compliance (including Operations, Regulatory and Policy Framework)
- Corporate Governance Compliance
- Support Risk Management
- Management Monitoring
- Compliance Policy/SOPs Formation, lunch and monitoring
- Compliance Maintenance to Pharmaceutical Laws across the countries where the Company operates.
**Compliance **(including Operations, Regulatory and Policy Framework)**:
- Contribute to maintenance of the Business Unit delivery and operational frameworks (Activities, deliverables, roles, and responsibilities) and ensure alignment to country regulations.
- Ensure Company activities align with SFDA (and equivalent outside Saudi) Regulatory requirements and liaise with commercial/marketing to ensure proper implementation of the regulations.
- Contribute to ensuring the Company is keeping up to date with regulatory and legal requirements through a pro-active knowledge management program in alignment with legal function.
- Ensure the Company and all its BU and functions adhere to its Bylaws, charters. Policies and authority levels.
- Support tracking and managing all CAPAs across BU, department and functions and escalate to top management and audit committee any significant gaps and findings.
**Corporate Governance Compliance**
- Ensure that the Company complies and adheres to all required regulatory filling and keeps up-to-date corporate registry and official documents.
- Ensuring that policies and SOPs are in place to ensure proper management and tracking of regulatory filling and disclosures including capital market authority requirements.
**Risk Management**
- Contribute to identification and initiation of Risk mitigation projects to address significant risks impacting the Company
- Facilitate risk identification and risk discussions within BU, both operational risk, regulatory and strategic risk
- Assist the Management to make risk informed decisions through a comprehensive Risk Dashboard
- Raise and approve (where necessary) Policy Exceptions and significant Risks
- Input into, review and enforce compliance within Policies and Standards as required within Business Unit
- Ensure emerging risks are identified and escalated appropriately and in a timely manner
- Perform GRC requirements within third party framework
- Ensure awareness of process and report suspected breach
- Provide training and education program to ensure ongoing awareness on new and updated Policies and Standards within the Company
**Audit Support**
- Contribute to ensuring Business Unit is ready to host external inspections from regulatory bodies
- Support management of overall Business Unit inspection readiness activities and CAPAs in liaison with the business
- Report status on CAPA’s to Business Unit RMCB
**Policy Formation**
- Create, review, and approve policy, standards, procedures, guidance, and training for compliance with relevant legislation and SOP Requirements.
- Support reviews of the commercial and marketing activities to make sure it complies with legislation and specifies any required changes within their Business Unit
**Basic Qualifications**
- Bachelor’s Degree in Pharmaceutical, Accounting.
- Have 7:10 years’ experience in Compliance and Risk Management.
- Experience in Pharmaceutical industry.
- Certifications in IFSA, CCA.
- Fluent in English and Arabic.
This advertiser has chosen not to accept applicants from your region.
9