Regulatory Affairs Specialist

1 month ago


Midrand, Gauteng, South Africa Emporium Full time
Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD)

Emporium is seeking a highly skilled Senior Regulatory Affairs Pharmacist to join our team in Midrand. As a key member of our regulatory affairs team, you will be responsible for managing work streams and reporting on assigned portfolios of products.

Key Responsibilities:

  • Manage internal product queries from relevant departments and external product queries from the SAHPRA, other MRA's and third-party stakeholders.
  • Establish regulatory priorities and allocate resources and workloads.
  • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Co-ordinate and submission of new product applications in South Africa and other applicable territories.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Conduct dossier due diligence to ensure all data gaps are addressed.
  • Prepare the registration applications for submission to the regulatory authorities.
  • Work in collaboration with internal and external stakeholders to assess regulator's submissions requirements.
  • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines.

Requirements:

  • 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.
  • Demonstrable experience across the product development, commercialization and maintenance lifecycle.
  • Sound project management capabilities.
  • Proven ability to consistently deliver to quality, time and cost standards.
  • Good Manufacturing Practices (GMP).
  • Pharmaceutical production experience or exposure to supplement regulatory knowledge.

What We Offer:

  • A competitive salary of R950 – R1m.
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.

How to Apply:

Send your MS Word format CV to jobs@emporium.co.za and use POS24325 – Snr RA Pharma in the subject line.



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