A Global Pharmaceutical Organization is looking to employ a Regulatory Affairs Manager with 5 – 10 years’ experience in a similar role.
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
Responsibilities
- Ensure 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)
- Update 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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