Regulatory Affairs Pharmacist

About the role

The Regulatory Affairs Pharmacist will lead the registration and post‑approval activities for vaccine products at South African Vaccine Producers, ensuring compliance with SAHPRA, SAPC and GMP standards.

Key responsibilities

• Compile, review and submit registration dossiers for new and existing products to SAHPRA.
• Manage post‑approval variations, renewals, pharmacovigilance and post‑marketing compliance.
• Act as the responsible pharmacist for all manufacturing, quality, regulatory, storage and distribution activities.
• Ensure labelling, packaging and advertising meet regulatory requirements.
• Provide regulatory strategy for product development and launches.
• Maintain up‑to‑date regulatory documentation, databases and submission records.
• Monitor legislative changes and advise on impact.
• Supervise pharmacy personnel and ensure competence and registration.
• Oversee quality management systems, SOPs, documentation control and product release.
• Handle inspections, audits, complaints, recalls and mandatory reporting.

Required profile

• Bachelor of Pharmacy (B.Pharm) – NQF Level 8.
• Registered pharmacist with the South African Pharmacy Council.
• Minimum 5 years regulatory affairs experience, including at least 2 years as a responsible pharmacist.
• Strong knowledge of SAHPRA processes, SAPC rules and GMP legislation.
• Proven ability to manage multiple regulatory projects simultaneously.

Required skills

• Regulatory submission preparation and management.
• GMP and pharmacovigilance compliance.
• Regulatory documentation and database control.
• Advanced computer skills for regulatory systems.