Regulatory Affairs Director for Africa
1 month ago
Estimated Salary: R1,200,000 - R1,800,000 per annum.
Job Description:- We are seeking an experienced Regulatory Affairs Manager to lead our Southern and Eastern Africa Region. The ideal candidate will have a strong background in regulatory affairs and management experience.
- Ensure a thorough and seamless product registration process and dossier maintenance across the region.
- Lead, manage, and execute strategic direction for regulatory affairs in Africa.
- Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations in accordance with global standards.
- Coordinate license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC).
- Develop and implement SOPs in line with Global SOPs and maintain regulatory documentation filing systems.
- Manage internal and external audits, ensuring compliance with current legislation and regulations.
- Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation.
- Maintain regulatory compliance and quality-related records, ensuring availability and retention.
- Coordinate product recall or market withdrawal when necessary.
- Bachelor of Pharmacy degree (Pharm)
- Matric qualification
- South African Pharmacy Council (SAPC) registration
- Valid Drivers License and Own vehicle
- At least 5-10 years of experience in Regulatory Affairs, including management experience.
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