Regulatory Affairs Pharmacist – Fixed-Term (12 months)

About the role

IQVIA's client, a leading healthcare and pharmaceutical organisation, is seeking an experienced Regulatory Affairs Specialist to join their regulatory team on a 12‑month fixed‑term contract based in Johannesburg. The role will manage regulatory activities across South Africa and selected Sub‑Saharan African markets, ensuring compliance while supporting product registrations, lifecycle management and regulatory initiatives.

Key responsibilities

• Manage product portfolios of registered products and products under review.
• Compile and submit regulatory dossiers, including new product registrations, variations, renewals and maintenance submissions.
• Support New Chemical Entity (NCE), CTD and electronic submissions.
• Liaise with regulatory authorities and respond to regulatory queries.
• Maintain regulatory licences and ensure timely renewals.
• Create and approve product artwork and labelling materials.
• Ensure compliance with regulations governing medicines, packaging, advertising and promotion.
• Monitor and communicate regulatory intelligence and legislative changes.
• Support quality and compliance activities, including audits and SOP implementation.
• Provide regulatory guidance and training to internal stakeholders where required.

Required profile

• BPharm degree.
• Registered with the South African Pharmacy Council (SAPC).
• Minimum 3 years' experience in pharmaceutical regulatory affairs.
• Proven experience with product registrations, variations, renewals and dossier maintenance.
• Strong understanding of regulatory requirements for pharmaceuticals and lifecycle management.
• Excellent communication, stakeholder management and project management skills.

Required skills

• eCTD
• DocuBridge
• SAHPRA Engagement Portal
• FTP
• Veeva Vault