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Senior Regulatory Affairs Pharmacist

3 weeks ago

Midrand, Gauteng, South Africa Emporium Human Capital Full time
About the Role

We are seeking a seasoned Senior Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. The ideal candidate will have extensive experience in human medicines, including complementary medicines and medical devices, with a strong background in regulatory affairs.

As a key member of our regulatory team, you will be responsible for managing work streams, reporting on product portfolios, and establishing regulatory priorities. You will also collaborate with internal and external stakeholders to assess regulator submission requirements and ensure compliance with relevant legislation, regulations, and guidelines.

Key Responsibilities
  • Manage work streams for assigned products, including internal and external product queries from various departments and regulatory authorities.
  • Establish regulatory priorities and allocate resources and workloads to ensure timely and accurate submissions.
  • Review regulatory agency submissions to ensure compliance with standards and timelines.
  • Develop regulatory strategies and implementation plans for new product applications.
  • Conduct dossier due diligence to address data gaps and prepare submissions for registration.
Requirements
  • 5+ years of experience in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices.
  • Demonstrable experience across the product development, commercialization, and maintenance lifecycle.
  • Sound project management capabilities and ability to prioritize tasks under tight deadlines.
  • Proven ability to consistently deliver quality results and maintain good manufacturing practices.
  • Excellent communication and collaboration skills, with the ability to network, liaise, and negotiate with stakeholders.
What We Offer

We offer a competitive salary range of R950,000 to R1,000,000 per annum, depending on experience. In addition, you will have the opportunity to work with a dynamic team, contribute to the growth and success of our organization, and develop your skills and expertise in regulatory affairs.

How to Apply

If you are a motivated and experienced professional looking for a challenging role in regulatory affairs, please submit your application. We look forward to hearing from you