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Animal Healthcare Regulatory Affairs / NPD Manager

Animal Healthcare Regulatory Affairs / NPD Manager

TAC RecruitmentJohannesburg, South Africa
12 hours ago
Job description

KEY RESPONSIBILITIES

Regulatory Compliance & Governance

  • 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

  • Bachelors 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
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    Regulatory Manager • Johannesburg, South Africa