Regulatory Affairs Manager Pharmacist NJhb

MVG Recruitment Specialists; Cape Town; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A dynamic opportunity for a Regulatory Affairs Manager in Cape Town, specializing in compliance and product registrations within the pharmaceutical sector. The ideal candidate will bring strategic oversight and project management skills, ensuring successful regulatory submissions and collaboration with stakeholders. Join a team focused on quality and continuous improvement in a fast-paced environment.

Qualifications

• 5 years experience in Regulatory Affairs, preferably human medicines.
• Hands-on experience with CTD/eCTD submissions.

Responsibilities

• Manage end-to-end regulatory submissions.
• Liaise with SAHPRA and other regulatory bodies.
• Mentor junior staff and support audits.

Skills

Leadership

Decision-Making

Problem-Solving

Education

Degree or Diploma in Pharmacy

Tools

Adobe Acrobat

Job description

We're Hiring: Regulatory Affairs Manager Gauteng!

Are you a seasoned Regulatory Affairs professional ready to take the lead in ensuring compliance and driving successful product registrations across multiple territories?

An exciting opportunity has opened up for a Regulatory Affairs Manager to join a dynamic team within the pharmaceutical sector. Reporting to the Head of Regulatory Affairs, you'll be instrumental in providing strategic regulatory oversight, managing a portfolio of products, and engaging with both internal stakeholders and external regulatory bodies.

What You'll Bring:

• A degree or diploma in Pharmacy with SAPC registration
• 5 years experience in Regulatory Affairs (preferably human medicines)
• Strong understanding of the product development lifecycle
• Project management expertise and cross-functional collaboration skills
• Hands-on experience with CTD / eCTD submissions
• Prior RA Management experience leading a small team

Key Responsibilities:

• Manage end-to-end regulatory submissions (new applications & maintenance)
• Liaise with SAHPRA, other MRAs, and 3rd party partners
• Allocate resources, set priorities, and ensure compliance with evolving regulations
• Maintain internal training, mentor junior staff, and support audits/inspections
• Keep up to date with relevant legislation and regulatory trends

What Makes You Stand Out:

• Strategic mindset with the ability to work under pressure
• Excellent leadership, decision-making, and problem-solving skills
• Passion for quality, compliance, and continuous improvement

If you thrive in a fast-paced, collaborative environment and want to play a key role in bringing medicines to market, this could be the next step in your career.

Interested? Send your CV to response at or apply online.

Required Experience: Manager

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