Regulatory Affairs Pharmacist – Johannesburg

About the role

The Regulatory Affairs Pharmacist will manage regulatory activities throughout the product lifecycle, from new product applications to post‑registration amendments, ensuring full compliance with SAHPRA and other authorities. Working closely with Marketing, Business Development, Procurement and the Responsible Pharmacist, you will support product launches and maintain dossier integrity while monitoring legislative changes.

Key responsibilities

• Compile and submit new product applications and post‑registration amendments.
• Respond to SAHPRA pre‑ and post‑registration committee recommendations.
• Maintain and update dossiers, product information leaflets (PI/PILs) and regulatory documentation.
• Ensure approval and compliance of packaging and promotional materials.
• Support product launches in collaboration with Marketing.
• Review and approve master batch documentation.
• Implement, review and maintain SOP compliance.
• Monitor legislative changes affecting regulatory affairs.
• Provide training and peer review of regulatory documents.

Required profile

• Bachelor of Pharmacy degree.
• Minimum 2 years’ experience in Regulatory Affairs within a regulated region (e.g., South Africa, Europe, UK, Australia, Canada, Japan).
• Strong working knowledge of regulatory systems and compliance processes.

Required skills

• Docubridge
• Sage
• Microsoft Excel
• Microsoft Word
• Microsoft PowerPoint
• Microsoft Outlook