Senior Regulatory Affairs Pharmacist

About the role

Austell Pharmaceuticals is seeking a Senior Regulatory Affairs Pharmacist to lead regulatory activities for its product portfolio in South Africa. The role combines strategic oversight of submissions with hands‑on mentorship of a growing regulatory team.

Key responsibilities

• Lead the preparation and submission of CTD/eCTD dossiers, including renewals, variations and product transfers.
• Manage the full regulatory product lifecycle, ensuring ongoing compliance with SAHPRA requirements.
• Act as the primary liaison with SAHPRA, coordinating responses to queries and inspections.
• Review promotional material, artwork and packaging for regulatory compliance.
• Support new product launches and business development initiatives across Marketing, Manufacturing, Supply Chain and Commercial functions.
• Mentor and develop members of the Regulatory Affairs team.
• Drive continuous improvement of regulatory systems and processes.

Required profile

• B.Pharm degree with current SAPC registration.
• Minimum 5 years of regulatory affairs experience in the pharmaceutical industry.
• Strong knowledge of SAHPRA regulations and CTD/eCTD submission standards.
• Proven ability to manage submissions independently and interact with authorities.
• Leadership or mentoring experience.
• Existing relationships with SAHPRA are advantageous.

Required skills

• CTD/eCTD dossier preparation.
• Regulatory document management systems (DocuBridge/eCTD or similar).
• SAHPRA regulatory liaison and query handling.

What we offer

• Opportunity to work on a diverse pharmaceutical portfolio.
• Collaborative environment that values innovation and continuous improvement.
• Professional growth and mentorship opportunities.
• Full‑time, office‑based role in Parktown, Johannesburg.