Regulatory Affairs Pharmacist

Job Title**:Regulatory Affairs Pharmacist (Full-Time)**
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. As we continue to expand, we are looking for a highly skilled **Regulatory Affairs Pharmacist** to join our Regulatory and Product Development team. This individual will play a key role in ensuring compliance with **SAHPRA** and other regulatory authorities while supporting product development initiatives.

**Key Responsibilities**:
**Regulatory Compliance & Documentation**
- Ensure compliance with local and international pharmaceutical regulations, including SAHPRA, WHO, and PIC/S guidelines.
- Prepare, update, and maintain regulatory dossiers in line with the latest MCC-SA regulated guidelines.
- Consult with regulatory authorities to stay updated on changes affecting the business.
- Oversee the regulatory clearance & registration process for pharmaceutical products, ensuring timelines and requirements are met.
- Maintain regulatory files and ensure all documentation is accurate and up to date.

**Product Development & Quality Assurance**
- Collaborate with R&D, clinical, manufacturing, and quality assurance teams to ensure regulatory requirements are met during product development.
- Oversee the product development process from conception to commercialization.
- Ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) throughout development.
- Review and approve product development plans, protocols, and reports.

**Regulatory Strategy & Compliance Management**
- Develop and implement regulatory strategies for new drug products and variations to existing products.
- Provide strategic guidance on regulatory pathways for specific products or projects.
- Perform internal audits to assess regulatory compliance and identify areas for improvement.
- Assist in corrective and preventative actions to ensure compliance and uphold the company’s integrity.

**Stakeholder Engagement & Training**
- Establish relationships with SAHPRA and other relevant regulatory bodies.
- Develop and maintain a network of regulatory consultants and legal entities in African markets.
- Provide regulatory training and guidance to internal teams.

**Minimum Requirements & Qualifications**

**Qualifications & Professional Registration**
- Bachelor’s or advanced degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or a related field.
- Registered Pharmacist with the South African Pharmacy Council (SAPC).

**Experience & Skills**
- Minimum 5 years’ experience in Regulatory Affairs within the pharmaceutical industry.
- Previous experience in Quality Assurance (QA) or Quality Control (QC) is advantageous.
- Proven track record of successful product submissions and registrations.
- Strong understanding of pharmaceutical regulations, guidelines, and industry best practices.
- Excellent technical writing and project management skills.
- Proficiency in Microsoft Office, database management, and online regulatory submissions.

**Behavioral Competencies**
- Strong interpersonal and communication skills.
- Ability to work independently and as part of a team.
- High attention to detail and ability to manage multiple priorities.
- Business acumen and the ability to influence internal and external stakeholders.

**How to Apply**

If you meet the above requirements and are passionate about regulatory affairs, we invite you to apply

📌 **Subject Line**: Application - Regulatory Pharmacist
â³ **Application Deadline**: 28 February 2025

🚀 _Join us in ensuring the highest standards in pharmaceutical compliance and innovation_