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Regulatory Affairs Manager

2 months ago

Midrand, Gauteng, South Africa Servier Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Servier. As a key member of our regulatory affairs department, you will be responsible for ensuring the seamless registration and maintenance of our products in the SEA Cluster.

Key Responsibilities
  • Lead and manage the regulatory affairs function, ensuring compliance with all relevant regulations and standards.
  • Develop and implement strategic plans for product registration and dossier maintenance, ensuring timely and efficient submissions.
  • Provide expert guidance on pharmacovigilance and quality assurance, ensuring adherence to global standards and regulations.
  • Manage and coordinate the implementation of safety updates, CMC/P&A updates, and license renewals.
  • Develop and maintain SOPs, ensuring alignment with global standards and regulations.
  • Manage internal and external audits, ensuring compliance with regulatory requirements.
  • Ensure regulatory documentation is accurate, complete, and up-to-date, and that all necessary records are maintained.
  • Coordinate product recalls and market withdrawals, as necessary.
  • Provide training and support to local staff on regulatory affairs, pharmacovigilance, and quality assurance.
  • Stay up-to-date with domestic and international laws and regulations, and ensure compliance with all relevant standards.
Requirements
  • B. Pharm (Bachelor of Pharmacy) and registration with the South African Pharmacy Council (SAPC).
  • Minimum 10 years' experience in Regulatory Affairs, with human medicine and biologicals experience.
  • Strong knowledge of product registration and dossier maintenance, pharmacovigilance, and quality assurance.
  • Excellent communication and project management skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
About Servier

Servier is a global pharmaceutical company committed to therapeutic progress to serve patient needs. We offer a dynamic and supportive work environment, with opportunities for professional growth and development. Our teams are recognized for their scientific excellence, and we are committed to creating a workplace that encourages diversity, inclusion, and well-being.