Post-Basic Pharmacist Assistant — Dispense & Care

Dis-Chem Pharmacies Limited; South Africa; On-site; ZAR 600,000 - 900,000; Full time

Job summary

IQVIA's client, a leading healthcare and pharmaceutical organisation, seeks a Regulatory Affairs Specialist for a 12‑month fixed‑term contract based in Johannesburg, South Africa. The role involves managing regulatory activities across SA and selected Sub-Saharan markets, ensuring compliance and supporting registrations and lifecycle management.

The ideal candidate has a BPharm and SAPC registration with at least 3 years of pharmaceutical regulatory affairs experience, including eCTD, DocuBridge

Qualifications

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

Responsibilities

• Manage regulatory activities across SA and selected Sub-Saharan markets.
• Compile and submit regulatory dossiers for registrations, variations and renewals.
• Support NCE, CTD and electronic submissions.
• Liaise with regulatory authorities and respond to queries.
• Maintain regulatory licences and renewals.
• Create and approve artwork and labeling in line with regs.
• Ensure compliance with medicines, packaging and promotion regulations.
• Monitor regulatory intelligence and regulatory changes.

Skills

Communication

Stakeholder management

Project management

Attention to detail

Education

SAPC registration

BPharm degree

Tools

eCTD

DocuBridge

SAHPRA Engagement Portal

FTP

Veeva Vault

Job description

Regulatory Affairs Specialist – 12 month fixed‑term contract (Johannesburg, South Africa)

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.

• 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 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.

EEO Minorities/Females/Protected Veterans/Disabled