Group Head of Regulatory Affairs – Healthcare Sector (Nairobi)

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