Regulatory & Quality Co-ordinator M/F

Groupe CFAO; South Africa; On-site; ZAR 420,000 - 660,000; Full time

Job summary

CFAO Healthcare South Africa is seeking a Regulatory & Quality Co-ordinator M/F to support regulatory and quality assurance functions. Ideal candidates are pharmacists (registered) or BSc grads with pharma experience, early in their careers, offering operational support across medicines, OTCs, devices and cosmetics.

The role covers regulatory submissions, QA processes, pharmacovigilance and cross-functional collaboration to ensure compliance and product safety across diverse healthcare products.

Qualifications

• Bachelor of Pharmacy or BSc with pharmaceutical industry experience.
• Registered Pharmacist with South African Pharmacy Council, if applicable.
• 0–3 years’ experience in regulatory affairs, quality assurance, pharmaceutical operations or healthcare compliance.

Responsibilities

• Regulatory Affairs Support: prepare, compile, submit and follow-up regulatory applications.
• Quality Assurance Support: maintain the Quality Management System and related SOPs.
• Pharmacovigilance and Safety Support: monitor safety communications and escalate as needed.
• Cross-functional Support: collaborate with Regulatory, QA, Medical, Commercial and Supply Chain teams.

Skills

Attention to detail

Written and verbal communication

Microsoft Office

AI tools

Education

Bachelor of Pharmacy

BSc with pharmaceutical experience

Registered Pharmacist (SA)

Tools

Microsoft Office

Regulatory databases

Job description

Position Title

Regulatory & Quality Co-ordinator M/F

Contract

Full-time

The Regulatory & Quality Co-ordinator will support the Regulatory Affairs and Quality Assurance functions for CFAO Healthcare South Africa. The role is intended for a registered pharmacist (Out of community service) or for a BSc graduate (with experience in pharmaceutical industry) who is early in their industry career and who can develop within the regulatory and quality environment, while providing operational support across registered medicines, OTC products, medical devices, cosmetics, food supplements and other healthcare products.

Key Responsibilities

Regulatory Affairs Support

• Assist with the preparation, compilation, submission and follow-up of regulatory applications.
• Support renewals, amendments, variations, licence updates and product information changes.
• Assist with the maintenance of regulatory trackers, submission records, approval letters and authority correspondence.
• Assist with the review of product information, labels, package inserts and artwork.
• Assist with the review of product claims aligned to approved product information and are appropriately substantiated.
• Support marketing, commercial and medical teams with compliant product communication.
• Support regulatory intelligence by monitoring relevant updates from health authorities and applicable legislation.
• Liaise with internal teams, external partners and local representatives where required.

Quality Assurance Support

• Support the maintenance of the Quality Management System.
• Assist with SOPs, work instructions, forms, training records and quality agreements.
• Support quality processes, including deviations, complaints, change controls, recalls and corrective action records.
• Monitor Quality and Product e-mail boxes for product complaints, deviations, etc.
• Assist with supplier and product compliance activities.
• Support inspection, audit and external assessment preparation.
• Assist with compliance activities linked to Good Pharmacy Practice, Good Distribution Practice and ISO 13485 where applicable.

Pharmacovigilance and Safety Support

• Monitor the Safety email box for incoming adverse events, CIOMS and/or E2B reports or signal.
• Support the routing of adverse event reports or product safety concerns to the relevant Pharmacovigilance team.
• Support with the escalation of safety, quality or regulatory concerns appropriately.
• Support documentation and follow-up where quality complaints may have safety implications.

Cross-functional Support

• Work with Regulatory Affairs, Quality Assurance, Medical, Commercial and Supply Chain teams.
• Assist with regulatory and quality input for new product opportunities.
• Provide day-to-day operational support to reduce pressure on senior RA and QA resources.

Minimum Requirements

• Bachelor of Pharmacy degree or Bachelor of Science, with relevant pharmaceutical experience.
• Registered Pharmacist with the South African Pharmacy Council, if applicable.
• 0–3 years’ experience in regulatory affairs, quality assurance, pharmaceutical operations or healthcare compliance.
• Good understanding of medicines and healthcare product compliance.
• Strong attention to detail.
• Good written and verbal communication skills.
• Strong document management and follow-up skills.
• Computer literate, particularly Microsoft Office and AI tools.

Advantageous Experience

• SAHPRA submissions or health authority interactions.
• Quality Management Systems.
• Good Pharmacy Practice or Good Distribution Practice.
• ISO 13485 or medical device experience.

Job location

Africa, South Africa