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Regulatory Affairs Pharmacist

2 months ago

Midrand, Gauteng, South Africa Emporium Human Capital Full time

Job Title: Regulatory Affairs Pharmacist

Company: Emporium Human Capital

Job Summary: We are seeking a highly skilled Regulatory Affairs Pharmacist to manage work streams, report on assigned portfolios, and establish regulatory priorities.

Key Responsibilities:

  • Manage internal and external product queries from relevant departments and regulatory authorities.
  • Coordinate and submit 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 registration applications for submission to regulatory authorities.

Requirements:

  • Bachelor's Degree in Pharmacy and registration with the South African Pharmacy Council.
  • Plus 5 years of experience in Regulatory Affairs, preferably in human medicines.
  • Sound project management capabilities and ability to prioritize and work to tight deadlines.
  • IT skills including Microsoft Office and experience in use of CTD software builder.

What We Offer:

  • A competitive salary and benefits package.
  • Opportunities for growth and professional development.
  • A collaborative and dynamic work environment.

Closing Date: Not specified