Regulatory Affairs Manager

Minimum RequirementsMatricPharm (Bachelor of Pharmacy)South African Pharmacy Council (SAPC) registrationValid Drivers License and Own vehicle5 10 years experience in Regulatory AffairsMust have management experienceResponsible for ensuring a thorough and seamless product registration process and dossier maintenanceResponsible for the Southern and Eastern Africa RegionLead, manage, and execute strategic directionManage 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 SOPsManage internal and external audits (e.g., Global & SAHPRA)Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislationManage product complaints and deviationsMaintain regulatory documentation filing systemEnsure regulatory compliance and quality-related records are available and retainedCoordinate product recall or market withdrawal when necessary