Regulatory Affairs Pharmacist

You will join GSK as a Regulatory Affairs Manager based in South Africa. You will manage regulatory submissions for new product applications and product lifecycle activities and support cross functional teams to maintain compliance with local regulatory requirements. You will work closely with colleagues in regulatory, quality, manufacturing and commercial teams. We value clear thinking, practical problem solving, collaboration and a focus on patient safety. This role offers progression, meaningful impact and the chance to help GSK unite science, technology and talent to get ahead of disease together.

• Compile and submit new product registrations, rebaseline dossiers, labelling and CMC variations in accordance with SAHPRA regulations, requirements, and GSK standards and strategies.
• Manage and maintain compliance, meeting performance targets of global projects, systems and databases.
• Control the safe keeping of regulatory documentation and ensure that registered details are easy to retrieve.
• Ensure product information is compliant with MA and product pack changes are implemented in compliance with regulations and aligned to supply chain planning.
• Review, verify and approve artwork proofs for printed matter for products marketed in South Africa.
• Review and approve advertising and promotional material in accordance with legal requirements and relevant Codes of Conduct.
• Coordinate all regulatory submissions and commitments, ensuring these are in alignment with regulatory requirements, agreed strategy and timelines.
• Coordinate with Content Delivery the management of product registration documents and Health Authority correspondence in regulatory databases and repositories.

• Bachelor of Pharmacy (B.Pharm) or equivalent pharmacy degree and current registration with the South African Pharmacy Council.
• Minimum 3 years' experience in pharmaceutical product registration, regulatory affairs or related role.
• Practical experience preparing CMC submissions, renewals or labelling changes.
• Good written and verbal communication skills with experience corresponding with regulatory authorities.
• Strong attention to detail and experience with document control and change control processes.
• Comfortable working to deadlines and managing multiple projects in a collaborative team environment.

• 5 or more years' experience in regulatory affairs, pharmaceutical registration or CMC lifecycle management.
• Experience with South African regulatory authority (SAHPRA) processes and inspections.
• Familiarity with regulatory databases and global regulatory systems.
• Strong interpersonal skills with experience working across global and local teams.
• Experience reviewing artwork and packaging components for regulatory compliance.
• Project management skills or experience leading small cross functional projects.

This role is on site in South Africa with occasional travel to regional offices or regulatory meetings as required. Hybrid working arrangements may be considered where business needs allow. We will discuss specific working arrangements during the selection process.

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.