Regulatory Affairs Pharmacist – Johannesburg

About the role

As a Regulatory Affairs Pharmacist you will manage regulatory activities across the product lifecycle, ensuring compliance with SAHPRA and other authorities. You will collaborate with Marketing, Business Development, Procurement and the Responsible Pharmacist to support product launches and maintain dossier integrity.

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/PIL) and other 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 knowledge of regulatory systems and compliance processes.

Required skills

• Experience with Docubridge.
• Experience with Sage.
• Proficiency in Microsoft Excel, Word, PowerPoint and Outlook.