Regulatory Affairs Pharmacist

Avacare Health Group; Cape Town; On-site; ZAR 600,000 - 850,000; Full time

Job summary

A leading pharmaceutical company seeks a Regulatory Affairs Pharmacist in Cape Town. This role involves ensuring compliance with regulations, supporting product development, and engaging with regulatory bodies. Ideal for candidates with a degree in Pharmacy and 5+ years of experience in Regulatory Affairs.

Qualifications

• Minimum 5 years experience in Regulatory Affairs within the pharmaceutical industry.
• Strong understanding of pharmaceutical regulations and guidelines.

Responsibilities

• Ensure compliance with local and international pharmaceutical regulations.
• Collaborate with R&D and quality assurance teams.
• Develop and implement regulatory strategies for new drug products.

Skills

Proofreading

Writing Skills

Strong interpersonal and communication skills

Attention to detail

Project management

Education

Bachelors or advanced degree in Pharmacy

Registered Pharmacist with SAPC

Job description

Job Title : Regulatory Affairs Pharmacist (FullTime)

Company : Barrs Pharmaceuticals Industries Pty Ltd

Reports to : General Manager

Overview

Barrs Pharmaceuticals is a leading pharmaceutical company committed to developing and delivering highquality 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 MCCSA 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 companys 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

• Bachelors 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.
• 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

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!

Required Experience :

Senior IC

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

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Pharmacist • Cape Town, Western Cape, South Africa