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Regulatory Affairs Lead

1 week ago

Johannesburg, Gauteng, South Africa Vela Personnel Full time
About the Role

Vela Personnel is seeking a Senior RA Pharmacist to manage regulatory affairs for South Africa and Southern Africa markets. This role will involve overseeing regulatory management, providing strategic guidance, and ensuring compliance with relevant regulations.

Key Responsibilities
  • Regulatory Management: Responsible for managing regulatory activities in South Africa and Southern Africa markets, including registration submissions and post-approval activities.
  • Strategic Guidance: Provide strategic guidance to commercial teams on regulatory matters, ensuring alignment with business objectives.
  • Compliance: Ensure that all regulatory documentation meets relevant requirements, applying knowledge of regulatory guidelines and best practices.
  • Team Leadership: Direct management of part of the portfolio, requiring close collaboration with regional regulatory staff and distributors.
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.