Regulatory Affairs Pharmacist

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 Manager
 

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.

Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Compiles and submits new product registrations, rebaseline dossiers, labelling and CMC variations in accordance with SAHPRA regulations and requirements, and GSK standards and strategies.
• Manages and maintains compliance and meets performance targets of global projects, systems and databases
• Controls the safe keeping of regulatory documentation and ensure that registered details are easy to retrieve.
• Ensures product information is compliant with MA and product pack changes are implemented in compliance with regulations and aligned to supply chain planning.
• Review, verification and approval of artwork proofs for printed matter for products marketed in South Africa
• Review and approval Advertising and Promotional material in accordance with legal requirements and relevant Codes of Conduct.
• Co-ordinates all regulatory submissions and commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines.
• Co-ordinates with Content Delivery the management of product registration documents and Health Authority correspondence in regulatory databases and repositories.

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals

- 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.

Preferred Qualification

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

- 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.

Work Location and Working Model

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.

What you can expect from us

You will join a team that supports your development through on-the-job learning and formal regulatory training. You will have clear objectives and regular feedback. You will work in a respectful and inclusive environment that values different viewpoints and practical solutions. If you are motivated by making a tangible difference and growing your regulatory career, we encourage you to apply.

How to apply

If this role sounds like a fit, please submit your CV and a short statement describing your relevant experience and motivation for the role. We look forward to learning more about you.

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. #LI-Remote

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.

Contact information:
You may apply for this position online by selecting the Apply now button.

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