Regulatory Affairs Specialist
1 day 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 a seamless product registration process and dossier maintenance.
Key Responsibilities:- Lead and manage the regulatory affairs function to ensure compliance with all regulations and pharmacovigilance requirements.
- Develop and implement strategic direction for regulatory affairs, ensuring alignment with business objectives.
- Manage and execute regulatory documentation, including SOPs, work instructions, and quality records.
- Provide input to the regulatory strategy and ensure compliance with industry standards and regulations.
- Manage product complaints and deviations, and maintain regulatory documentation filing systems.
- Ensure regulatory compliance and quality-related records are available and retained.
- Coordinate product recall or market withdrawal when necessary.
- Obtain and distribute updated information on domestic and international laws.
- Report ADRs to Global Safety and SAHPRA, and follow up on Adverse Drug Reactions.
- B. Pharm (Bachelor of Pharmacy) degree.
- Registration with the South African Pharmacy Council (SAPC).
- Minimum 10 years of 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, APQRs, customer complaints.
- Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa.
- Microsoft Office Suite proficiency.
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