Manager/Associate Director, Labelling Strategy & Governance

GSK; City Of London; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading global pharmaceutical company is seeking a Labelling Strategy and Governance Manager/Associate Director based in the UK. The ideal candidate will lead the development of the Global Datasheet and work closely with global teams to ensure accurate patient and prescriber information. Applicants should have a life sciences or pharmacy degree, with relevant experience in regulatory affairs and strong communication skills. This role offers hybrid work options and a competitive package.

Benefits

Competitive salary

Annual bonus based on performance

Healthcare and wellbeing programmes

Pension plan membership

Shares and savings programme

Qualifications

• Experience or interest in developing patient and prescriber information.
• Relevant labelling experience such as pharmacy, regulatory affairs, or clinical research.
• Track record of authoring clear scientific labelling text.

Responsibilities

• Lead the development of the Global Datasheet for new oncology products.
• Develop prescribing and patient information for EU markets.
• Manage documentation to support global and regional product information development.

Skills

Regulatory affairs

Communication skills

Attention to detail

Leadership skills

Education

Life sciences/pharmacy degree

Tools

Veeva vault

Job description

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.

At GSK, we're constantly developing new products and improving our established medicines and vaccines to improve the quality of human life by enabling people to do more, feel better and live longer. Ensuring these products are correctly prescribed and used is essential, and that's where our labelling team is key. The Labelling Strategy and Governance team supports our portfolio of medicines and vaccines by ensuring that the information relating to the safety and efficacy of our products reaches patients and prescribers. This is done through the creation and management of our Global Datasheet, which contains information for prescribers and patients.

As a Labelling Strategy and Governance Manager/Associate Director based in the UK, you will help us support our exciting pipeline of new products. This includes primarily work on the Global Datasheet as well as the European SmPC and Package Leaflet. As this is a global role, you will also provide labelling support to colleagues in markets worldwide.

Our Labelling Strategy and Governance team supports a product during development and throughout its early lifecycle, and we are the authors of Global Datasheets for GSK products. You will liaise with colleagues in Clinical, Safety, Regulatory and other company functions to ensure that the Prescribing Information and Patient Leaflets accurately state the Company's medical and scientific position regarding the safe and effective use of a GSK product.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK.

In this role you will:

• 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).

Basic Qualifications & Skills:

• 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.

Preferred Qualifications & Skills:

• 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 weigh 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.

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.

Find out more: Our approach to R&D.

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.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail] or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.