Regulatory Affairs Pharmacist

About the role

The Regulatory Affairs Pharmacist will lead the registration, compliance and post‑approval activities for vaccine products at South African Vaccine Producers. This senior position ensures that all pharmaceutical operations meet South African legislation, GMP standards and company policies.

Key responsibilities

• Compile, review and submit registration dossiers for new and existing products to SAHPRA.
• Manage post‑approval activities including variations, renewals, pharmacovigilance and post‑marketing compliance.
• Act as the Responsible Pharmacist, overseeing pharmaceutical, manufacturing, quality, regulatory, storage and distribution activities.
• Ensure regulatory compliance of labelling, packaging and advertising materials.
• Provide regulatory strategy for product development, launches and business growth.
• Maintain up‑to‑date regulatory documentation, databases and submission records.
• Monitor legislative and regulatory changes affecting the South African pharmaceutical industry.
• Supervise pharmacy personnel, ensure proper registration, competence and scope of practice.
• Manage regulatory 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 (SAPC).
• Minimum 5 years’ experience in Regulatory Affairs, including at least 2 years as a Responsible Pharmacist.
• Strong knowledge of SAHPRA processes, GMP, the Pharmacy Act and related legislation.
• Proven ability to manage multiple projects and regulatory responsibilities concurrently.

Required skills

• Regulatory submissions and dossier preparation.
• GMP compliance and quality management systems.
• Pharmaceutical legislation interpretation.
• Technical documentation and database management.
• Advanced computer skills for regulatory databases.

What we offer

• Opportunity to lead regulatory affairs for a leading vaccine manufacturer.
• Collaborative, team‑oriented environment.
• Professional development in a high‑impact sector.