Pharma Regulatory & Quality Coordinator

CFAO; Sandton; On-site; ZAR 300,000 - 420,000; Full time

Job summary

CFAO Healthcare South Africa seeks a Regulatory & Quality Co-ordinator to support Regulatory Affairs and QA. The role is suitable for a registered pharmacist or a BSc graduate with pharmaceutical experience, aiming to grow within regulatory and quality environments across medicines, OTC, medical devices, cosmetics and other healthcare products.

You will work with cross-functional teams to prepare submissions, maintain quality systems, monitor safety signals and assist with compliance activities.

Qualifications

• 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, QA, 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.

Responsibilities

• 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 regulatory intelligence by monitoring relevant updates from health authorities and applicable legislation.
• Liaise with internal teams, external partners and local representatives where required.
• 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.
• 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.
• 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.

Skills

Attention to detail

Documentation management

Written & verbal communication

Microsoft Office

Education

Bachelor of Pharmacy

Bachelor of Science (pharma experience)

Tools

AI tools

Microsoft Office

Job description

CFAO Healthcare South Africa seeks a Regulatory & Quality Co-ordinator to support Regulatory Affairs and QA. The role is suitable for a registered pharmacist or a BSc graduate with pharmaceutical experience, aiming to grow within regulatory and quality environments across medicines, OTC, medical devices, cosmetics and other healthcare products.

You will work with cross-functional teams to prepare submissions, maintain quality systems, monitor safety signals and assist with compliance activities.