Regulatory Pharmacist

About the role

The Regulatory Pharmacist will lead the management of regulatory activities for pharmaceutical products, ensuring timely approvals and ongoing compliance with both local and international requirements. This role works closely with cross‑functional teams to support product registrations, lifecycle maintenance, and regulatory strategy.

Key responsibilities

• Prepare, compile, review and submit regulatory dossiers for new product registrations, renewals and variations.
• Manage the lifecycle maintenance of registered pharmaceutical products.
• Liaise with national regulatory authorities, including SAHPRA, to address product registrations and queries.
• Interpret and implement changes in pharmaceutical legislation and guidelines.
• Review labeling, package inserts, promotional materials and artwork for compliance.
• Provide regulatory support to Quality Assurance, Manufacturing, Medical Affairs, Marketing and Supply Chain.
• Maintain regulatory databases and document‑management systems.
• Develop regulatory strategies to facilitate timely product approvals.
• Coordinate responses to authority questions and deficiency letters, and support inspections and audits.
• Mentor junior regulatory pharmacists and officers, and participate in cross‑functional launch teams.

Required profile

• Bachelor of Pharmacy (BPharm) or equivalent degree.
• Registration as a pharmacist with the relevant national pharmacy council.
• 5–8 years of pharmaceutical regulatory affairs experience.
• Proven experience with product registration, lifecycle management and interaction with regulatory authorities.
• Experience preparing CTD/eCTD submissions.
• Experience with prescription medicines, OTC products and/or biologics.

Required skills

• CTD/eCTD dossier preparation.
• Use of SAHPRA electronic submission portals.
• Regulatory database management.
• Document‑management system proficiency.
• Good Regulatory Practices (GRP) knowledge.
• Good Manufacturing Practice (GMP) knowledge.