Regulatory Affairs Pharmacist

Regulatory Affairs Pharmacist

Parktown, Johannesburg

About the Role

As a Regulatory Affairs Pharmacist, you will be responsible for managing regulatory activities across the product lifecycle from new product applications to post-registration amendments, ensuring full compliance with SAHPRA and other regulated authorities.

You will work closely with Marketing, Business Development, Procurement, and the Responsible Pharmacist, supporting product launches, maintaining dossier integrity, and staying ahead of legislative changes that impact marketability.

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, 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

Minimum Requirements

• 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

Technical Skills

• Experience with tools such as:
• Docubridge
• Sage
• Microsoft Excel, Word, PowerPoint & Outlook

Working Environment

• Office-based in Parktown, Johannesburg
• Occasional travel to SAHPRA and suppliers

Apply now and take the next step in your Regulatory Affairs career!