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