Regulatory Affairs Pharmacist

GSK; Sandton; Hybrid; ZAR 600,000 - 900,000; Full time

Job summary

GSK in Johannesburg, South Africa, is seeking a Regulatory Affairs Pharmacist to oversee regulatory submissions and ensure compliance for local product registrations. You will work with regulatory, quality, and commercial teams to navigate the South African framework and accelerate approvals.

In this hybrid role, you will leverage your BPharm and SAPC registration with 3–5 years of regulatory experience to build robust submissions, manage labeling reviews, and maintain strong regulatory

Qualifications

• BPharm degree and SAPC registration.
• 3–5 years of regulatory affairs experience.
• Strong knowledge of South African regulatory frameworks and the Medicines and Related Substances Act.
• Excellent communication and attention to detail for cross‑functional collaboration.

Responsibilities

• Prepare and submit regulatory dossiers and applications to support product approvals and market access in South Africa.
• Ensure ongoing regulatory compliance by monitoring changes in regulations and updating documentation accordingly.
• Collaborate closely with cross‑functional teams including marketing, supply chain, quality, and medical affairs to align regulatory requirements with business needs.
• Lead the review and approval process for product labeling and promotional materials to ensure compliance with local regulations and company policies.
• Build and maintain strong relationships with regulatory authorities and external partners to support successful product registrations and issue resolution.
• Contribute to improving regulatory processes and sharing insights that support faster, more efficient product launches and lifecycle management.

Skills

Regulatory affairs

Pharmaceutical compliance

Stakeholder management

Attention to detail

Education

BPharm degree

Registration with SAPC

Tools

Regulatory submission systems

Job description

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D

Regulatory Affairs Pharmacist

Join a passionate and dedicated team at GSK focused on making a difference in healthcare. As a Regulatory Affairs Pharmacist based in South Africa, you will play a vital role in ensuring our products meet all regulatory requirements. You will collaborate with diverse teams, acting as a key partner in navigating regulations and accelerating product approvals. We value candidates who are curious, proactive, and committed to maintaining high standards while seeking continuous growth. This role offers you the chance to grow your career, contribute to meaningful health impacts, and be part of our mission to unite science, technology, and talent to get ahead of disease together.

Responsibilities:

• Prepare and submit regulatory dossiers and applications to support product approvals and market access in South Africa.
• Ensure ongoing regulatory compliance for products by monitoring changes in regulations and updating documentation accordingly.
• Collaborate closely with cross‑functional teams including marketing, supply chain, quality, and medical affairs to align regulatory requirements with business needs.
• Lead the review and approval process for product labelling and promotional materials to ensure compliance with local regulations and company policies.
• Build and maintain strong relationships with regulatory authorities and external partners to support successful product registrations and issue resolution.
• Contribute to improving regulatory processes and sharing insights that support faster, more efficient product launches and lifecycle management.

Why You?

Basic Qualification

• Bachelor of Pharmacy (BPharm) degree or equivalent qualification in pharmacy.
• Registration as a Pharmacist with the South African Pharmacy Council (SAPC) or relevant professional body.
• At least 3-5 years of experience in Regulatory Affairs or a related function within the pharmaceutical or healthcare industry.
• Solid understanding of South African Medicines and Related Substances Act and applicable regulatory frameworks.
• Strong attention to detail and ability to interpret and apply complex regulatory information clearly.
• Excellent communication skills, with the ability to influence and build effective working relationships across functions and with external agencies.

Preferred Qualification

If you have the following characteristics, it would be a plus:

• Experience working within pharmaceutical regulatory affairs in South Africa.
• Knowledge of dossier preparation for product registrations, variations, and renewals under current local regulations.
• Familiarity with labelling requirements and advertising codes for pharmaceutical products.
• Proven project management skills and ability to handle multiple priorities with a structured approach.
• Additional qualifications such as a Master’s degree in Regulatory Affairs, Pharmacy, or a related field.
• Experience using electronic regulatory submission systems and regulatory intelligence tools.

Work Model

This is a hybrid position based in Johannesburg, South Africa, offering the chance to work closely with local and regional teams while engaging in cross‑functional collaboration.

Why GSK?

You will join a team focused on patient outcomes and scientific excellence. You will have development opportunities and access to global expertise. You will work in a supportive environment that values inclusion, respect and open feedback. If you are ready to use your clinical knowledge and relationship skills to make a difference, please apply today. We welcome applicants from all backgrounds.

What we offer

You will join an organisation that aims to make a real difference to patients. We invest in learning and development to help you grow. You will work with people who value inclusion and diverse perspectives. If you want to build a meaningful career in oncology and help shape better outcomes for patients, we encourage you to apply.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Skills

Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Stakeholder Management

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.