Healthcare Regulatory Manager

2 weeks ago

Johannesburg, South Africa Marvel Placement Consultants Full time

**Healthcare Regulatory Manager & NPD Specialist**

**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**:
Submissions for this vacancy will close on 09 September 2025, however, you will still have the opportunity to submit your CV for this position till 02 October 2025.

**Please Note**:
**PoPI Act**:
Please note that Marvel Placement Consultants adhere to the POPI Act (Act No. 4 of 2013: Protection of Personal Information Act, 2013). Section 9 of PoPI states that “Personal Information may only be processed if, given the purpose for which it is processed, it is adequate, relevant and not excessive”.

For more information please contact:
**Consultant KC

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