• Ensure compliance of healthcare, pharmaceutical, food, nutritional, veterinary, and medical device portfolios with SAHPRA, Act 36, and international regulations.
• Oversee product registrations, renewals, amendments, and dossier upgrades.
• Monitor, interpret, and implement changes in regulations, advising business and marketing teams.
• Approve and sign off product labelling, packaging, and marketing material in line with regulatory and advertising standards.
• Lead regulatory audits, compliance reviews, and risk assessments.

New Product Development (NPD) & Innovation

• Provide regulatory input during concept, development, and launch stages.
• Support formulation, actives sourcing, and compliance of new product pipelines.
• Draft and review product information leaflets, labels, and inserts.
• Project manage timelines for dossier submissions and new product launches.

Quality & Manufacturing Oversight

• Ensure adherence to GMP, PQMS, and site compliance requirements.
• Conduct gap analyses on dossiers and quality systems, implementing corrective actions.
• Develop validation protocols, product release protocols, and SOPs.

Exports & International Registrations

• Manage product registrations in SADC and other markets.
• Build and maintain relationships with international regulatory bodies.

Stakeholder Engagement & Risk Management

• Act as regulatory advisor to cross-functional teams.
• Maintain detailed regulatory project records and ensure clear audit trails.
• Identify, assess, and mitigate regulatory risks across business operations.

QUALIFICATIONS & EXPERIENCE

• Bachelor’s Degree in Pharmacy, Food Science, Nutrition, or related field.
• 5+ years’ experience in animal health regulatory affairs (healthcare and/or food).
• Strong knowledge of SAHPRA, Act 36, GMP & IAMA certification and international regulatory frameworks,
• Proven track record of managing product registrations, dossiers and NPD compliance.
• Experience liaising with regulatory authorities, managing audits, and driving compliance initiatives.