Regulatory Affairs Specialist and Responsible Pharmacist

About the Job:

🚨 WE’RE HIRING | URGENT APPOINTMENT 🚨

Regulatory Affairs Specialist & Responsible Pharmacist

📍 Location: Pretoria, Gauteng

🕘 Type: Full-time | On-site

🏥 Industry: Medical Devices

⚡ Immediate availability highly preferred

📩 Interested?

Apply now or tag someone who would be a great fit.

👉 Please complete the criteria assessment here:

https://www.ondemandassessment.com/o/JB-BAVXR1M0M/landing?u=1169243

Role Description

Envision Africa is seeking a qualified and detail-oriented Regulatory Affairs Specialist who will also act as the Responsible Pharmacist.

This role is responsible for ensuring compliance with pharmaceutical and medical device regulations, maintaining regulatory licences and product registrations, overseeing controlled substances and product release, and supporting the organisation’s Quality Management System.

The successful candidate will work closely with Quality Assurance, Production, Customer Services, Product Management, Procurement, Warehousing and the Sub-Saharan Africa team to maintain regulatory compliance and support the continued growth of the organisation.

🛠 What You’ll Do

• Act as the Responsible Pharmacist.
• Ensure compliance with the Pharmacy Act, Medicines and Related Substances Act, GMP and GDP requirements.
• Maintain and renew SAHPRA licences, permits and regulatory authorisations.
• Review batch documentation and authorise the release of pharmaceutical products.
• Manage controlled substances, including procurement records, reconciliations and regulatory documentation.
• Maintain pharmacovigilance processes and coordinate the reporting of adverse events.
• Manage local and international product and medical device registrations.
• Support regulatory registrations across Sub-Saharan African markets.
• Maintain regulatory dossiers, Medical Device Files, SOPs and controlled documentation.
• Conduct and maintain supplier evaluations and regulatory risk classifications.
• Coordinate product recalls and adverse incident investigations where required.
• Support environmental and product bioburden monitoring.
• Assist with audit preparation, audit findings, CAPAs and quality assurance activities.
• Monitor regulatory changes and communicate new requirements to relevant stakeholders.
• Provide regulatory guidance and training to internal departments.

👤 What We’re Looking For

• Bachelor of Pharmacy (BPharm) degree.
• Active registration with the South African Pharmacy Council.
• At least 2–3 years’ experience in regulatory affairs, preferably within the pharmaceutical or medical device industry.
• Knowledge of SAHPRA licensing, product registrations, GMP, GDP and ISO 13485:2016.
• Experience working with Quality Management Systems, SOPs and regulatory documentation.
• Strong attention to detail and excellent organisational skills.
• The ability to communicate complex regulatory requirements clearly.
• A proactive, process-driven and collaborative approach.
• Experience with product registrations in African markets will be advantageous.

⭐ Why Join Us

• Join a growing and well-established medical device and pharmaceutical organisation.
• Take ownership of an important regulatory and professional function.
• Gain exposure to pharmaceutical, medical device and international regulatory processes.
• Work across Quality Assurance, Production, Procurement and commercial departments.
• Contribute directly to regulatory compliance, patient safety and continuous improvement.
• Become part of a professional and collaborative team where accuracy and accountability matter.