6 Regulatory Affairs 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 17 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.
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