Regulatory Affairs Pharmacist

1 week ago

Johannesburg, Gauteng, South Africa 09252f65-4f3d-4a62-bbc7-224ffe181f43 Full time R900 000 - R1 200 000 per year

Role Description

This is a full-time on-site role for a Regulatory Affairs Pharmacist, based in Woodmead, Gauteng. The Regulatory Affairs Pharmacist will be responsible for ensuring compliance with regulatory requirements and maintaining up-to-date knowledge of pharmaceutical laws and guidelines.

Responsibilities include:

  • Responsible for new product applications.
  • Compilation and submission of Post Registration amendments to ensure dossier compliance.
  • Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure product registration.
  • Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation
  • Approval of master batch documentation prior to product production.
  • Responsible for SOP implementation/review, update and compliance.
  • Managing and maintaining regulatory documentation filing system.
  • Ensuring regulatory compliance and quality related records are available and retained.
  • Ensure on-going regulatory compliance of the existing product portfolio.
  • Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products
  • Liaise with business development for regulatory requirements prior to dossier acquisition.
  • Training and peer review of documents.
  • To ensure approval and compliance of printed packaging material and promotional marketing material.
  • Liaising with marketing department to facilitate timeous launch of products.
  • Building and maintain effective working relationships with both the South Africa and India regulatory teams.

Qualifications & Minimum Requirements

  • 5 years experience as a Regulatory Affairs Pharmacist.


  • Bachelor's degree in Pharmacy (B.Pharm)
  • Registration as a Pharmacist with the South African Pharmacy Council (SAPC).
  • Strong expertise in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs in the South African Pharmaceutical industry
  • Excellent written and verbal communication skills
  • Analytical skills and attention to detail to ensure compliance with industry regulations

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