Regional Regulatory Affairs Manager – GMENA
Beirut, Lebanon
Full timeRemote
Job description
About Genpharm
Genpharm is a pharmaceutical company operating across the Middle East and North Africa, dedicated to delivering high-quality healthcare solutions to patients throughout the region.
We are seeking an experienced Regional Regulatory Affairs Manager to coordinate regulatory activities across our markets and report directly to the Head of Department. The role will be responsible for supporting successful product registrations, managing product lifecycles, ensuring ongoing regulatory compliance, and maintaining effective engagement with health authorities and key internal and external stakeholders.
The Opportunity:
As a Regional Regulatory Affairs Manager, you will play a key role in shaping and executing the regional regulatory strategy, supporting product registrations and launches, and ensuring regulatory activities are managed effectively across multiple markets.
This role requires strong regional regulatory expertise, particularly across GCC and MENA markets, combined with the ability to work independently, manage multiple priorities, and collaborate effectively with cross-functional and international stakeholders.
Key Responsibilities:
- Lead and oversee regional Regulatory Affairs activities across assigned MENA and GCC markets.
- Prepare, review, compile, and coordinate regulatory submissions, including CTD/eCTD dossiers and country-specific requirements.
- Manage regulatory submission timelines and follow up with Health Authorities to ensure timely approvals and registrations.
- Review and coordinate responses to Health Authority queries, deficiency letters, and regulatory requests.
- Provide regulatory guidance on product labeling, packaging, artwork, storage requirements, and Patient Information Leaflets (PILs).
- Maintain oversight of regulatory certificates, licenses, renewals, variations, and other regulatory documentation.
- Maintain an accurate and up-to-date regional regulatory database and submission tracker.
- Monitor regulatory changes across relevant markets and communicate their potential impact to internal and external stakeholders.
- Build and maintain effective relationships with Health Authorities, local distributors, regulatory partners, and global/regional stakeholders.
- Collaborate closely with cross-functional teams including Commercial, Supply Chain, Medical, Quality, Pharmacovigilance, and other relevant functions to support successful product launches and ongoing business activities.
- Support regulatory requirements related to tenders, product registrations, and other business requests as needed.
- Ensure regulatory activities are aligned with applicable local regulations, company standards, and regional requirements.
- Provide regulatory expertise and guidance to internal teams and external partners across assigned markets.
What We’re Looking For:
- Bachelor’s degree in Pharmacy, Life Sciences, or a related scientific discipline.
- 5-8 years of progressive experience in Regulatory Affairs, preferably within the pharmaceutical industry.
- Strong hands-on experience across MENA markets, with solid exposure to GCC regulatory environments.
- Strong knowledge of CTD/eCTD submissions, new product registrations, renewals, variations, and regulatory lifecycle management.
- Proven experience in dealing with Health Authorities and regulatory requirements across multiple countries.
- Experience working with local distributors, regional partners, and/or multinational pharmaceutical organizations is highly desirable.
- Strong understanding of regional regulatory requirements and the ability to translate regulatory requirements into practical business actions.
- Excellent stakeholder management, communication, organizational, analytical, and problem-solving skills.
- Ability to work independently and effectively in a remote, regional, and cross-functional environment.
- Fluent English is required; Arabic is preferred.
- Fluent French is a strong plus.
- Familiarity with Quality Control (QC) and Pharmacovigilance (PV/QV) processes is a plus, with the ability to collaborate effectively with relevant functions.
Why This Role?
This is an opportunity to take ownership of regional Regulatory Affairs activities and work closely with diverse stakeholders across multiple markets, contributing directly to product access, regulatory strategy, and business growth across the region.