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 / South African regulatory landscape
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People Management, Strategic Thinking, Regulatory Compliance, Stakeholder Management, Project Management, Policy Implementation, Pharmacovigilance, Regulatory Operations, Regulatory Submissions, Cross-Functional Teamwork
Preferred skills
Experience in Sub-Saharan Africa, Knowledge of South African pharmaceutical legislation
Technologies
Regulatory databases, internal systems
Responsibilities
Lead and develop the Regulatory Affairs team; Develop and execute regulatory strategies; Ensure timely submission and lifecycle management of marketing authorisations; Monitor and communicate regulatory intelligence; Build relationships with health authorities; Represent Regulatory Affairs in inspections and audits; Drive regulatory policy engagement; Administer the departmental budget.
Seniority
Senior, hands-on IC with people leadership
