Regulatory Affairs Manager

3 days ago

Cape Town, South Africa Avacare Health Group Full time

Job Title**:Regulatory Affairs Manager (Full-Time) In Office**
Location: Ndabeni, Cape Town
Company: Barrs Pharmaceuticals Industries Pty Ltd
Reports to: General Manager

**Overview**
Barrs Pharmaceuticals is a leading pharmaceutical company committed to developing and delivering high-quality, compliant healthcare solutions. The **Regulatory Affairs Manager** will support the regulatory compliance and product registration activities across the business. This role ensures that all pharmaceutical products meet applicable regulatory standards and supports the efficient progression of product development, licensing, and submissions.

**Key Responsibilities**:

- Assist in the compilation, submission, and lifecycle management of regulatory dossiers for new and existing products.
- Maintain compliance with South African and neighbouring countries' regulatory requirements.
- Ensure all documentation is accurate, up to date, and stored per company policies and regulatory expectations.
- Coordinate with internal departments such as Quality Assurance, Quality Control, and Production for regulatory input and documentation.
- Assist in audits and corrective/preventative action processes as required.
- Contribute to regulatory strategy discussions and participate in training initiatives.
- Establish and maintain strong communication channels with regulatory authorities and external consultants.

**Minimum Requirements & Qualifications**:

- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or a related discipline.
- 5 years’ experience in a regulatory, quality assurance, or pharmaceutical manufacturing environment.
- Working knowledge of pharmaceutical regulations and dossier requirements in South Africa (SAHPRA) and SADC regions.
- Strong attention to detail and document management skills.
- Proficient in Microsoft Office and online regulatory submission systems.
- Effective communication and interpersonal skills.
- Ability to work both independently and collaboratively in a cross-functional team.

**Behavioural & Cultural Competencies**
- High attention to detail and commitment to compliance.
- Strong interpersonal and networking skills.
- Proactive and solutions-driven approach.
- Ability to work in a culturally diverse environment.
- Integrity, professionalism, and passion for pharmaceutical quality and safety.

**How to Apply**
If you meet the above requirements and are passionate about regulatory affairs, we invite you to apply
Subject Line: Application - Regulatory Affairs Manager
- Application Deadline**:30 May 2025**

Join us in ensuring the highest standards in pharmaceutical compliance and innovation

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