Senior Regulatory Affairs Pharmacist

About the role

Austell Pharmaceuticals is looking for an experienced Senior Regulatory Affairs Pharmacist to lead regulatory activities across its product portfolio in South Africa. The role ensures compliance with SAHPRA legislation, manages product lifecycle, and provides technical leadership to the Regulatory Affairs team.

Key responsibilities

• Lead regulatory compliance in line with SAHPRA and other pharmaceutical regulations.
• Compile, review and submit CTD/eCTD dossiers for registrations, renewals, variations and transfers.
• Coordinate responses to SAHPRA queries and manage submission timelines.
• Oversee product lifecycle activities such as PI/PIL updates, labeling changes and approved variations.
• Review promotional materials, artwork and packaging for regulatory compliance.
• Collaborate with Marketing, Manufacturing, Supply Chain and Business Development on regulatory matters.
• Mentor and guide Regulatory Affairs team members and drive continuous improvement of processes.

Required profile

• B.Pharm degree with current SAPC registration.
• Minimum 5 years of regulatory affairs experience in the pharmaceutical industry.
• Proven experience mentoring or leading regulatory affairs projects or teams.
• Established relationships with SAHPRA are highly advantageous.

Required skills

• CTD/eCTD dossier compilation and submission.
• Proficiency with DocuBridge/eCTD or similar regulatory document management systems.