Regulatory Affairs Pharmacist

About the role

A leading healthcare and pharmaceutical organisation, acting through IQVIA, is seeking an experienced Regulatory Affairs Specialist for its Regulatory team on a 12-month fixed-term contract based in Johannesburg. The role manages regulatory activities across South Africa and selected Sub-Saharan African markets, supporting product registrations, lifecycle management and regulatory compliance.

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 licenses 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 and registration with the South African Pharmacy Council (SAPC).
• At least 3 years of experience in pharmaceutical regulatory affairs.
• Proven experience with product registrations, variations, renewals and dossier maintenance.
• Preferred: experience across South Africa and other Sub-Saharan African markets, knowledge of quality management systems, and direct engagement with regulatory authorities.

Required skills

• eCTD, DocuBridge, SAHPRA Engagement Portal, FTP, Veeva Vault
• Strong understanding of pharmaceutical regulatory requirements and lifecycle management
• Communication, stakeholder management and project management skills
• Attention to detail and ability to manage multiple priorities