Healthcare Regulatory Manager & NPD Specialist at Marvel Placement Consultant

Healthcare Regulatory Manager & NPD Specialist 

• A leading player in the pet food manufacturing and healthcare industry is seeking a Healthcare Regulatory Manager & New Product Development (NPD) Specialist to strengthen their Regulatory Affairs team.
• This role is pivotal in ensuring compliance with local and international regulatory standards, while simultaneously driving product innovation and supporting business growth.
• The successful candidate will be responsible for managing product registrations, maintaining a robust Quality Management System (QMS), and providing technical guidance throughout the NPD process—ensuring products are compliant, market-ready, and aligned with strategic objectives.

Minimum Requirements 

• Essential: Relevant Bachelor’s degree (e.g. Pharmacy, Health Sciences, Regulatory Affairs). 
• Advantageous: Additional qualifications in Quality Assurance, Regulatory Compliance, or Manufacturing Sciences. 
• Experience: Minimum 5 years in regulatory affairs or NPD, with exposure to pharmaceutical, medical device, complementary, nutritional, and V- or G-registrations. 
• Demonstrated experience with dossier development, submissions, and regulatory approvals. 
• Strong working knowledge of SAHPRA, Act 36, GMP, and international registration processes. 
• Proven background in QMS development and pharmaceutical manufacturing compliance. 

Key Responsibilities 

Regulatory Affairs 

• Lead the preparation, submission, and follow-up of new product registrations and renewals. 
• Conduct dossier gap analyses, recommend corrective actions, and ensure timely approvals. 
• Build and maintain a centralised database of product registrations, legal documents, and timelines. 
• Act as the primary liaison with regulatory authorities and external stakeholders. 

Quality Management Systems (QMS) 

• Design, implement, and maintain SOPs, quality manuals, and QMS integrations. 
• Oversee site compliance activities including updates to the Site Master File. 
• Monitor adherence to GMP standards and drive continuous quality improvement. 

New Product Development (NPD) 

• Provide regulatory expertise during product design, formulation, and label development. 
• Ensure new products meet both regulatory and commercial requirements. 
• Collaborate with marketing, manufacturing, and legal teams to align innovation pipelines. 
• Draft and review product inserts, labels, and information leaflets. 

Manufacturing & Validation 

• Approve manufacturing processes, equipment validations, and supplier quality checks. 
• Oversee batch release procedures, ensuring all testing and documentation are in order. 
• Sign off manufacturing specifications and ensure regulatory alignment. 

Exports & International Registration 

• Manage submissions for SADC and international markets, ensuring compliance with foreign regulations. 
• Maintain strong networks with global registration bodies to support expansion strategies. 

Skills & Competencies 

• Strong sense of urgency and results orientation. 
• High attention to detail, with excellent planning and organisational ability. 
• Independent decision-maker with strong collaboration skills. 
• Creative problem-solving with resilience under pressure. 
• Ability to simplify complex regulations into actionable business strategies. 

 Preferred Experience & Knowledge 

• G/V/Complementary product registrations. 
• Regulatory dossier submissions and renewals. 
• Quality systems setup and pharmaceutical manufacturing compliance. 
• Healthcare and nutritional product development. 

Closing Date:

• 2025-10-02