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.
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.
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.
Requirements:
- 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 Qualifications:
- 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.
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.