Regulatory Affairs Manager

Johannesburg, Gauteng, South Africa

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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

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