Regulatory Affairs Manager

Minimum Requirements Matric Pharm (Bachelor of Pharmacy) South African Pharmacy Council (SAPC) registration Valid Drivers License and Own vehicle 5 10 years experience in Regulatory Affairs Must have management experience Responsible for ensuring a thorough and seamless product registration process and dossier maintenance Responsible for the Southern and Eastern Africa Region Lead, manage, and execute strategic direction Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations. Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC) Write and develop SOPs in line with Global SOPs Manage internal and external audits (e.g., Global & SAHPRA) Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation Manage product complaints and deviations Maintain regulatory documentation filing system Ensure regulatory compliance and quality-related records are available and retained Coordinate product recall or market withdrawal when necessary