Manager/Associate Director, Labelling Strategy & Governance

Are you an enthusiastic regulatory professional with experience or an interest in developing patient and prescriber information while pursuing a career in a global pharmaceutical company? If so, GSK currently has an opportunity in its Global Regulatory Affairs (GRA) Labelling Strategy and Governance department, within Research and Development, and this Labelling role may be an ideal opportunity for you to explore.

• Lead the development of the Global Datasheet for new oncology products or product line extensions.
• Develop prescribing and patient information for EU markets. Manage core and local prescribing/patient information through development and for newly approved products.
• Work with colleagues in markets worldwide to ensure implementation of the Global Datasheet into local prescribing/patient information.
• Author responses to regulatory questions on prescribing/patient information from Regulatory Authorities. Author documentation to support Labelling Governance Committees. Interface with key labelling and governance stakeholders across GSK.
• Manage documentation to support global and country/regional product information development and early maintenance. Author and manage EU product information annexes for products registered via the EU centralised procedure.
• Manage GRA Labelling data in appropriate systems and databases (primarily Veeva vault).

• Life sciences/pharmacy degree (or equivalent)
• Relevant labelling experience such as pharmacy, regulatory affairs, medical affairs, clinical research, pharmacovigilance, or therapeutic area experience. Broad experience in regulatory affairs, ideally in labelling activities.
• Track record of authoring clear scientific labelling text for health professionals and patients.
• Fluency in English.

• Advanced degree (or equivalent) in Pharmacy, life sciences or similar discipline.
• Specific experience with prescribing/patient information.
• Proven leadership skills. Experience in managing senior stakeholders to meet internal and external deadlines.
• Proactively seeks information, guidance, and insight from a broad range of sources and weighs benefits and risks before making important decisions.
• Demonstrated high attention to detail and accuracy. Ability to work in complex matrix teams. Excellent communication skills.
• Show a focus on improving performance and excellence in all tasks. Challenge ways of working to seek improved process.

Closing Date for Applications: 25th November 2025 EOD

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

Find out more: Our approach to R&D

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.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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