Group Head of Regulatory Affairs – Healthcare Sector

This role is critical in shaping regulatory strategy, ensuring compliance, and enabling successful market expansion for both human pharmaceutical and animal health products.

Key Responsibilities

• Regulatory Strategy: Lead the development and execution of regulatory strategies.
• Dossier Preparation: Manage ACTD/CTD dossier preparation and submissions.
• Lifecycle Management: Oversee product registrations, renewals, variations, and overall lifecycle management.
• Regional Engagement: Coordinate regulatory engagement across multiple African countries.
• Cross-functional Collaboration: Partner with CMOs, CROs, QA, R&D, and Supply Chain teams.
• Digital Systems: Implement and manage Regulatory Information Management Systems (RIMS) and other digital platforms.
• Leadership: Provide team leadership, capability building, and performance management.

Requirements

• 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.