Regulatory Affairs Manager

A Global Pharmaceutical Organization is looking to employ a Regulatory Affairs Manager with 5 – 10 years' experience in a similar role.
Minimum RequirementsMatricPharm (Bachelor of Pharmacy)South African Pharmacy Council (SAPC) registrationValid Drivers License and Own vehicle5 – 10 years' experience in Regulatory AffairsMust have management experienceResponsibilitiesEnsure 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 variationsHandle 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)Update 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
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