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Healthcare Regulatory Manager & NPD Specialist

Healthcare Regulatory Manager & NPD Specialist

Marvel Placement ConsultantJohannesburg, Gauteng, South Africa
21 days ago
Job description

Job title : Healthcare Regulatory Manager & NPD Specialist

Job Location : Gauteng, Johannesburg

Deadline : October 03, 2025

Overview

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 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.

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    Regulatory Specialist • Johannesburg, Gauteng, South Africa