Regulatory Affairs Pharmacist

IQVIA Argentina; Centurion; On-site; ZAR 600,000 - 900,000; Full time

Job summary

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

The role requires a BPharm degree and SAPC registration with at least 3 years in pharmaceutical regulatory affairs, including dossier maintenance and interaction with

Qualifications

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

Responsibilities

• Manage regulatory activities for SA and selected Sub-Saharan markets.
• Compile and submit regulatory dossiers including registrations, variations and renewals.
• Support NCE, CTD and electronic submissions.
• Liaise with regulatory authorities and respond to queries.
• Maintain licenses and renewals.

Skills

Regulatory affairs

Stakeholder management

Project management

Attention to detail

Communication skills

Education

BPharm degree

SAPC registration

Tools

eCTD

DocuBridge

SAHPRA Portal

FTP

Veeva Vault

Job description

Regulatory Affairs Pharmacist

Location: Johannesburg, South Africa
Contract Type: Fixed-Term Contract (12 Months)

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.