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Regulatory Affairs Manager Professional

1 week ago

Johannesburg, Gauteng, South Africa MVG Recruitment Specialists Full time

MVG Recruitment Specialists seeks a highly skilled Regulatory Affairs Manager to lead their Regulatory team.

This role requires strong leadership skills, project management capabilities, and experience in Regulatory Affairs within the pharmaceutical industry.

About the Role

The successful candidate will be responsible for ensuring legal compliance with relevant medicine regulatory authorities, processing regulatory applications, and managing work streams.

  • Manage work streams for assigned portfolios and report on progress.
  • Assist internal departments with product queries and external stakeholders with SAHPRA and third-party inquiries.
  • Review and submit new product applications in South Africa and other territories.
Key Requirements
  • Bachelor's degree in Pharmacy or Diploma in Pharmacy, registration with the SAPC.
  • Minimum 5 years of experience in Regulatory Affairs, preferably in human medicines.
  • Experience with CTD software builder and eCTD application compilation is an advantage.

Leadership Skills: Strong people management, prioritization, and decision-making abilities.