Associate Director, Regulatory Affairs
Core
Lead the Regulatory Affairs team to secure timely approvals and maintain optimal product positioning for medicines in South Africa and Sub-Saharan Africa.
Role type
Senior IC regulatory affairs director (pharmaceuticals)
Builds
Marketing authorisations, variations, renewals, and major indications for pharmaceutical products
Domain
Pharmaceuticals / Healthcare
Required skills
Regulatory strategy, stakeholder management, team leadership, compliance management, policy engagement, submission lifecycle management, budget administration, cross-functional collaboration, strategic planning, regulatory intelligence
Preferred skills
Experience in Sub-Saharan Africa, knowledge of South African pharmaceutical legislation
Technologies
Regulatory databases, submission systems
Responsibilities
Lead and develop the Regulatory Affairs team; execute regulatory strategies for product approvals; manage marketing authorisation lifecycle; engage with health authorities and industry associations; drive policy advocacy; administer departmental budget; ensure compliance with local regulations and quality standards.
Seniority
Senior, hands-on IC with people management
