Senior Regulatory Affairs Pharmacist

We're Hiring | Senior Regulatory Affairs Pharmacist

Parktown, Johannesburg | Full-Time | Office-Based

Are you an experienced Regulatory Affairs Pharmacist looking to take the next step in your career?

Austell Pharmaceuticals is looking for a highly motivated Senior Regulatory Affairs Pharmacist to join our Regulatory Affairs team. This is an exciting opportunity to play a strategic role in managing regulatory submissions, supporting new product launches, driving compliance, and mentoring a growing team of regulatory professionals.

What You'll Be Doing:

• Lead regulatory submissions including CTD/eCTD dossiers, renewals, variations and transfers
• Manage regulatory product lifecycle activities
• Liaise with SAHPRA and coordinate responses to regulatory queries
• Review promotional material, artwork and packaging for compliance
• Support new product launches and business development initiatives
• Mentor Regulatory Affairs team members
• Drive continuous improvement of regulatory systems and processes
• Collaborate across Marketing, Manufacturing, Supply Chain and Commercial teams.

What We're Looking For

• B.Pharm degree with current SAPC registration
• Minimum 5 years' Regulatory Affairs experience within the pharmaceutical industry
• Strong knowledge of SAHPRA requirements and CTD/eCTD submissions
• Experience with regulatory document management systems (DocuBridge/eCTD or similar)
• Proven ability to independently manage regulatory submissions and authority interactions
• Leadership or mentoring experience
• Existing proven relationships with SAHPRA will be advantageous.

Why Join Austell?

At Austell Pharmaceuticals, you'll have the opportunity to work on a diverse product portfolio while contributing to meaningful healthcare solutions. We value collaboration, innovation, continuous improvement, and professional growth.