Date | 2024-10-23 |
---|---|
Job Title | Regulatory Affairs Manager |
Employer | Fusion Personnel More Information |
Salary | 130000 |
Category | Medical |
Location |
Gauteng / Gauteng |
Job Summary
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
Regulatory Affairs Manager position available in Gauteng, Gauteng. This job position was posted by Fusion Personnel. The job has been posted as a char8000 ad on 2024-10-23 at 01:00:46 in the Medical category
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