Senior Regulatory Affairs Specialist

1 day ago


Midrand, Gauteng, South Africa Emporium Full time
Job Description:

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Emporium.

About the Role:

  • This is a senior-level position responsible for managing regulatory work streams and reporting on assigned portfolios of products.
  • The ideal candidate will have demonstrable experience across the product development, commercialization, and maintenance lifecycle.
  • Proven ability to consistently deliver to quality, time, and cost standards.
  • Good Manufacturing Practices (GMP) experience or exposure to supplement regulatory knowledge.

Main Responsibilities:

  1. Manage work streams for internal product queries from relevant departments and external product queries from regulatory authorities and stakeholders.
  2. Establish regulatory priorities and allocate resources and workloads.
  3. Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards.
  4. Coordinate and submit new product applications in South Africa and other applicable territories.
  5. Develop regulatory strategies and implementation plans for the preparation and submission of new products.

Required Skills and Qualifications:

  • Bachelor's Degree in Pharmacy, Diploma in Pharmacy, and Registration with the South African Pharmacy Council.
  • +-5 years' experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.
  • Sound project management capabilities.
  • Ability to prioritize and work to tight deadlines.
  • IT skills, including Microsoft Office.

Benefits:

  • R950 – R1m estimated salary based on industry standards.
  • A competitive benefits package, including medical aid, retirement fund, and annual leave.
  • An opportunity to work with a dynamic team in a fast-paced environment.

Closing Date: We encourage applicants to submit their CVs as soon as possible. Please use POS24325 - Snr RA Pharma in the subject line.



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