Regulatory & Quality Co-ordinator M/F

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

With a revenue of over €_8.3 billion, access to 45 of the 54 countries on the continent, and near to 23,100 employees, we are a key player in mobility, infrastructure and energy, healthcare and, consumer goods,.

The Group partners with leading international brands and covers the entire value chain - imports, production and distribution- in line with the best international standards, drawing on over 170 years of hands-on knowledge and local expertise.

We pursue a twofold strategy, focusing on manufacturing to promote local production, and distribution through its distribution network, Africa's largest, to offer tailored, affordable products and services to people across the continent.

With Africa For Africa

More information: www.cfaogroup.com

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

Experience in any of the following would be beneficial:

SAHPRA submissions or health authority interactions.

Quality Management Systems.

Good Pharmacy Practice or Good Distribution Practice.

ISO 13485 or medical device