Regulatory Affairs Pharmacist – 12-Month Contract

Dis-Chem Pharmacies Limited; Pretoria; In loco; ZAR 700.000 - 1.000.000; Tempo pieno

Descrizione del lavoro

IQVIA, a leading healthcare insights provider, seeks an experienced Regulatory Affairs Specialist to join the regulatory team on a 12-month fixed-term contract based in Johannesburg. You will manage regulatory activities across South Africa and selected Sub-Saharan markets, ensuring compliance and supporting registrations, lifecycle management, and regulatory initiatives.

The role requires a BPharm degree and SAPC registration, plus 3+ years in regulatory affairs, with strong communication and

Competenze

• BPharm degree with SAPC registration.
• Minimum 3 years in pharmaceutical regulatory affairs.
• Experience with product registrations, variations, renewals and dossier maintenance.

Mansioni

• Manage product portfolios of registered products and those under review.
• Compile and submit regulatory dossiers (new registrations, variations, renewals, maintenance).
• Support NCE, CTD, and electronic submissions.
• Liaise with regulatory authorities and respond to queries.
• Maintain regulatory licenses and ensure timely renewals.
• Create and approve product artwork and labeling materials.
• Ensure compliance with medicines regulations, packaging, advertising and promotion.
• Monitor regulatory intelligence and changes in legislation.
• Support quality, audits and SOP implementation.
• Provide regulatory guidance and training to internal stakeholders.

Conoscenze

Regulatory expertise

Regulatory submissions

Project management

Formazione

BPharm degree

SAPC registration

Strumenti

eCTD

DocuBridge

SAHPRA Portal

FTP

Veeva Vault

Descrizione del lavoro

IQVIA, a leading healthcare insights provider, seeks an experienced Regulatory Affairs Specialist to join the regulatory team on a 12-month fixed-term contract based in Johannesburg. You will manage regulatory activities across South Africa and selected Sub-Saharan markets, ensuring compliance and supporting registrations, lifecycle management, and regulatory initiatives.

The role requires a BPharm degree and SAPC registration, plus 3+ years in regulatory affairs, with strong communication and