Role Overview:
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:
Education
- Bachelor of Pharmacy degree
Experience
- Minimum 2 years’ experience in Regulatory Affairs within a regulated region (e.g. South Africa, Europe, UK, Australia, Canada, Japan)
Skills & Competencies
- Strong working knowledge of regulatory systems and compliance processes
- Experience with tools such as: Docubridge, Sage, Smartsheet, Sweet Process, Microsoft Excel, Word, PowerPoint & Outlook
- Takes ownership and works with integrity and confidentiality
- Has strong attention to detail and thrives under deadlines
- Communicates clearly and works well cross-functionally
- Is organised, assertive, conscientious, and patient
- Keeps regulatory excellence at the centre of everything you do
APPLY NOW and take your career to the next level with Austell!
