9 Customs Regulations jobs in Egypt

**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

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.

Requirements About the company Flow Talent have been sourcing the best Banking, Technology, Financial Services & Legal professionals locally and internationally for leading organisations across the Middle East region since 2018. Through years of experience, we know there is significant demand for highly skilled professionals and pride ourselves on having the highest calibre candidates. As a team, we strive to help our clients achieve operational and business excellence by identifying quality talent, quickly, through our collaborative approach. Flow place professionals in the following sectors: - Banking & Financial Services - Digitalisation & Technology - Legal & Compliance We help our clients with: - Contingent Recruitment: - Retained Recruitment - Emiratization and Saudization - Market Entry

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

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

**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.

Description
Are you an experienced trade compliance leader passionate about cross-border trade? Come make history in Amazon's Global Trade Services team supporting Amazon's cross-border operations and trade lane expansions. Amazon is looking for a Sr Trade Compliance Manager to drive critical large-scale cross-functional projects. You will enable new business opportunities by executing on a broad range of project management, program management and trade compliance matters. You will work directly with business leadership, tax, legal, catalog, inventory management, procurement teams, logistics, and other internal business partners to drive projects that address critical business and regulatory requirements. In this role, you will be part of a team responsible for the development of the strategies, policies, processes, tools and solutions that will be a key enabler for cross-border movement of goods into Egypt.
This candidate will be a self-starter with strong knowledge of Trade Compliance, Regulatory Affairs, Regulators and cross-border movements of goods in Egypt with a strong track record of delivering projects that involves coordination across different functions. To be successful in this role, you will be a Trade Compliance professional and demonstrate an on-going curiosity and creativity, balanced with the ability to distill numerous inputs/ideas into meaningful actions and recommendations. Strong Project Management skills are required to be successful in this role. This is an exciting and challenging position that provides Trade Compliance support to Amazon's Retail business by acting as the SME leader to a team obsessed with ensuring Amazon's successful adherence to trade regulations. This role is responsible for defining and enforcing regulatory requirements, and driving Amazon policy at scale. You must be able to interface effectively and communicate convincingly with leaders at all levels, including the executive leadership team. You will demonstrate the ability to work well and influence strategically in both small team and large, cross-functional environments. As part of this, you will build and leverage a network of stakeholders and internal customers who will help both validate and challenge your approach / recommendations in a constructive fashion. The right candidate must have a record of accomplishment in Trade Compliance and program ownership. This is your opportunity to work in a highly visible space and be part of a fast-growing company!
Key job responsibilities
In this role you will
- Manage GTS Trade Compliance program for Egypt to ensure customs and adhere to various cross-border compliance requirements.
- Work with Amazon's Global Trade Services team to execute strategy, drive and enforce global import / export processes, seek automation opportunities and leverage technologies.
- Engage with technical teams to influence road-map for internal systems used to carry out import and export operations.
- Drive scalable business solutions and ensure compliance with trade regulations.
- Liaise with authorities and manage customs brokers involved in Amazon's import process to Egypt.
- Collaborate with business units to proactively identify compliance issues and comply with regulatory obligations
- Work with manufactures/vendors to set up import processes to support importing/exporting operations.
- Partner with service leaders across Amazon to identify and influence the development of new programs/products and services
A day in the life
In this role no two days will be exactly the same but regular activities will include:
- Engaging directly with regulators, including but not limited to Egypt Customs on trade related matters.
- Working with business, legal and logistics stakeholders to develop strategies to support rapid growth of Amazon's import and export programs.
- Collaborating with technical teams to define requirements for Amazon's systems, driving relevant import and export programs.
- You will be responsible to ensure the accuracy in import declarations - including classification, customs valuation, other regulations.
- Working with operations teams to troubleshoot issues and drive ongoing process improvements
About the team
Global Trade Services (GTS) empowers customers, vendors, sellers and internal partners to efficiently move compliant and safe products, technology, and software across borders. We build import/export solutions to place the right products in the right destinations at the right time and cost. We expertly navigate increasing regulatory compliance complexity to mitigate risk, increase predictability and earn trust with external stakeholders.
Basic Qualifications
- 6+ years of compliance, audit or risk management experience
- Knowledge of Microsoft Office products and applications at an advanced level
- Bachelor's degree or equivalent
Preferred Qualifications
- Project Management Professional (PMP) or equivalent certification
- Experience leveraging technology and implementing lean principles / Six Sigma methodologies to drive process improvements or equivalent
- Master's degree or equivalent
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner.

**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.

Alpha Capital offers a steady and challenging career path. It boasts a friendly environment where management is always accessible and where no topics are beyond discussion. All of this is coupled with a heavy investment in the training and development of our staff.

**Key responsibilities**:

- Minimum 5 years of work experience

**Relevant skills, knowledge, and experience**
- Minimum 5 years of experience.