Group Head of Regulatory Affairs âÃÂàHealthcare Sector (Nairobi) at Talent Grid Africa
Talent Grid Africa
This role is critical in shaping regulatory strategy, ensuring compliance, and enabling successful market expansion for both human pharmaceutical and animal health products.
The successful candidate will lead:
Regulatory strategy development and execution
ACTD/CTD dossier preparation and submissions
Product registrations, renewals, and lifecycle management
Regulatory engagement across multiple African countries
Coordination with CMOs, CROs, QA, R&D, and Supply Chain teams
Implementation of RIMS and digital regulatory systems
Team leadership, capability building, and performance management
Key Requirements
To be considered for this role, candidates should have:
Bachelor's degree in Pharmacy, Veterinary Medicine, Pharmaceutical Sciences, or a related scientific field
Minimum 7+ years of regulatory affairs experience within the pharmaceutical industry, with exposure to African markets
Strong experience in ACTD/CTD dossier preparation, submission, and review
Proven experience in product registrations, renewals, variations, and lifecycle management
Experience working with both locally manufactured products and CMOs (preferred)
Experience coordinating bioequivalence studies with CROs (preferred)
Strong understanding of pharmaceutical regulatory frameworks across multiple African countries
Experience with regulatory systems, tracking tools, or RIMS platforms is an added advantage
Strong leadership, stakeholder management, and cross-functional collaboration skills