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!

📧 Email your CV and cover letter to [email protected]
📌 Subject Line: Application – Regulatory Pharmacist
⏳ Application Deadline: 28 February 2025

🔹 Only shortlisted candidates will be contacted.

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