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PharmacyComplianceSupply chainCommunicationProject management
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About the role
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:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
- 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
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