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Animal Healthcare Regulatory Affairs / NPD Manager
TAC RecruitmentJohannesburg, Gauteng, South Africa2 days ago
Job descriptionProvide 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. 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. Manage product registrations in SADC and other markets. Build and maintain relationships with international regulatory bodies. 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. 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. Role can be based in either Gauteng or Cape Town
SUMMARY
SUMMARY :
An exciting opportunity to lead animal health regulatory affairs across multiple categories — from healthcare and pharmaceuticals to food and nutrition — while contributing to product innovation and business growth.
POSITION INFO
KEY RESPONSIBILITIES
Regulatory Compliance & Governance
- Ensure compliance of healthcare, food, nutritional, veterinary, and 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 standards.
- Lead regulatory audits, compliance reviews, and risk assessments.
New Product Development (NPD) & Innovation
Quality & Manufacturing Oversight
Exports & International Registrations
Stakeholder Engagement & Risk Management
QUALIFICATIONS & EXPERIENCE
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Regulatory Manager • Johannesburg, Gauteng, South Africa
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