Regulatory Affairs and Clinical Affairs Manager

About the role

Direct and manage the Regulatory and Clinical Affairs (RCA) department to ensure best‑practice regulatory compliance and clinical information for the manufacture, sale and safe use of quality pharmaceutical products in line with SAHPRA and international standards.

Key responsibilities

• Provide regulatory and clinical input into the company’s strategic planning and review processes.
• Ensure compliance with national and international legislation, maintaining product licences and legal documents.
• Conduct dossier due‑diligence, manage variations, new registrations and define regulatory strategies.
• Support business objectives by identifying optimal regulatory approaches for specific markets and monitoring regulatory developments.
• Oversee pharmacovigilance activities, adverse‑event reporting, safety‑committee meetings and promotional compliance.
• Deliver clinical information services, manage the specialist library and respond to literature enquiries.

Required profile

• Pharmacy degree (BPharm) and M.Sc. Clinical Pharmacy or equivalent postgraduate qualification.
• Registered with the South African Pharmacy Council.
• Minimum 5 years experience in South African pharmaceutical regulatory environment and 3 years in medicines information services.
• At least 3 years senior management experience leading and coaching teams.
• Strong understanding of pharmaceutical quality systems and cGMP principles.

Required skills

• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).
• Experience with MS Access, Lotus Notes, InforMED, PCV Manager or similar databases.
• Use of bibliographic management software.
• Knowledge of clinical trials processes.
• Familiarity with SAP (advantage).