Regulatory Affairs Pharmacist at IQVIA

About the Opportunity

• 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.
• This role will be responsible for managing regulatory activities across South Africa and selected Sub-Saharan African markets, ensuring compliance with applicable regulatory requirements while supporting product registrations, lifecycle management, and regulatory compliance 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 licenses and ensure timely renewals.
• Create and approve product artwork and labelling materials.
• Ensure compliance with applicable regulations governing medicines, packaging, advertising, and promotion.
• Monitor and communicate relevant regulatory intelligence and changes in legislation.
• Support quality and compliance activities, including audits and SOP implementation.
• Provide regulatory guidance and training to internal stakeholders where required.

Minimum Requirements

• 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.

Working knowledge of:

• eCTD
• DocuBridge
• SAHPRA Engagement Portal
• FTP
• Veeva Vault
• Strong understanding of regulatory requirements for pharmaceuticals and lifecycle management.
• Excellent communication, stakeholder management, and project management skills.
• Strong attention to detail and ability to manage multiple priorities.

Preferred Experience

• Experience working across South Africa and other Sub-Saharan African markets.
• Knowledge of quality management systems and pharmaceutical compliance requirements.
• Experience engaging directly with regulatory authorities.

What We're Looking For

• The successful candidate will be a proactive, detail-oriented regulatory professional with strong technical expertise and the ability to work effectively across cross-functional teams. You will thrive in a fast-paced environment and be passionate about ensuring regulatory compliance while enabling successful product commercialisation.

Important Information

• This is a 12-month fixed-term contract position based in Johannesburg, South Africa.