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Pharmaceutical Regulatory Specialist

1 week ago

Johannesburg, Gauteng, South Africa Vela Personnel Full time
Regulatory Affairs Career Opportunity

Vela Personnel is seeking a highly experienced Regulatory Affairs Pharmacist to join our team in Johannesburg. This role offers the opportunity to develop expertise in regulatory affairs for South Africa and Southern Africa markets, working on high-profile regulatory projects.

Key Responsibilities
  • Regulatory Projects: Manage regulatory projects, including registration submissions and post-approval activities, ensuring compliance with relevant regulations.
  • Regulatory Strategy: Develop and implement regulatory strategies to support business objectives, working closely with commercial teams.
  • Team Leadership: Direct management of part of the portfolio, requiring close collaboration with regional regulatory staff and distributors.
  • Knowledge Base: Maintain up-to-date knowledge of regulatory requirements and guidelines in assigned countries.
Requirements
  • Qualifications: Bachelor's degree in Pharmacy, registered with the South African Pharmacy Council. MSc, MBA or PhD may be an advantage.
  • Experience: Minimum 8 years of experience in regulatory affairs, preferably in human medicines, with proven experience in registration submissions and regulatory knowledge on South Africa, Botswana, and Namibia market guidelines.
  • Leadership Skills: Proven ability to manage complex regulatory issues, lead cross-functional teams, and deliver results in a matrix environment.