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Regulatory Affairs Specialist
2 months ago
Hire Resolve's client is seeking a highly skilled Regulatory Affairs Manager to join their team in Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring seamless product registration and dossier maintenance, while ensuring compliance with all regulations and pharmacovigilance requirements.
Key Responsibilities- Develop and execute strategic direction for regulatory affairs.
- Ensure regulatory documentation meets relevant requirements and specifications.
- Provide input to regulatory strategy in line with business objectives.
- Manage safety updates and implement quality management systems.
- Handle license renewals and manage product complaints.
- Develop and maintain SOPs and manage internal and external audits.
- Responsible for updates of dossiers and product information.
- Ensure regulatory compliance and quality-related records are available.
- Coordinate product recall or market withdrawal when necessary.
- B. Pharm (Bachelor of Pharmacy) degree.
- Registration with the South African Pharmacy Council (SAPC).
- Minimum 10 years' experience in Regulatory Affairs with human medicine and biologicals experience.
- Product registration and dossier maintenance experience.
- Pharmacovigilance experience and knowledge of SAHPRA submission portals.
- Launch procedures for new products.
- QA processes and customer complaints experience.
- Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa.
- Microsoft Office Suite proficiency.
Hire Resolve offers a competitive salary and a dynamic work environment.
Contact Hire Resolve for more information.