Associate Director - Global Regulatory Affairs (Oncology Therapeutic Group)

GSK; Waver; Hybrid; EUR 98,000 - 164,000; Full time

Job summary

GSK is seeking an Associate Director of Global Regulatory Affairs. This role develops and executes global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance.

You will report to the Global Regulatory Lead and collaborate with cross-functional teams to shape development plans and regulatory interactions across regions. You will lead with a patient-first mindset, driving strategic changes, stakeholder engagement, and

Qualifications

• Bachelor’s degree in biological, pharmaceutical or healthcare science.
• Experience in all phases of drug development in regulatory affairs, preferably oncology.
• Experience with clinical trial and licensing requirements in major regions.
• Experience leading regional development, submission and approval activities.
• Strong written and verbal communication; senior stakeholder management.
• Experience working in matrix teams.

Responsibilities

• Develop and deliver robust regulatory strategies with GRL and regional teams.
• Collaborate with cross-functional teams to align regulatory plans with asset strategy.
• Support interactions, reviews and submissions with regional authorities.
• Assess regulatory intelligence to inform strategy and decision-making.
• Ensure compliance across product lifecycle and drive process improvements.

Skills

Regulatory strategies

Stakeholder management

Regulatory compliance

Matrix leadership

Digital fluency

Communication

Business resilience

Resource management

Education

Bachelor’s degree in biological, pharmaceutical or healthcare science

Job description

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

Position Summary

As Associate Director - Global Regulatory Affairs at GSK you will develop and execute global and regional regulatory strategies for oncology assets, ensuring optimal labelling and approvals while maintaining compliance with internal and external requirements. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head and collaborate with cross-functional teams to shape development plans and regulatory interactions across multiple regions. We value clear thinking, collaboration, practical problem solving and a patient-first mindset.

Responsibilities (include..,)

• Work closely with GRL, global/regional counterparts and local operating companies to develop and deliver robust regulatory strategies that meet key market requirements.
• Collaborate with cross-functional teams to align regulatory plans with Medicines Development Strategy and Integrated Asset Plan.
• Support interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval.
• Assess regulatory intelligence, precedents and competitive landscape to inform strategy development and improve decision-making.
• Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle.
• Drive process improvement, innovation, and performance excellence through the development and implementation of strategic changes.

Location

This role is based in GSK HQ in London UK, Stevenage UK or alternatively in Switzerland Baar Onyx or Belgium - Wavre. The working pattern is hybrid, combining time in the office and remote work.

Please Note – If the successful applicant is based at Stevenage site: This role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge UK, in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

APPLICATION CLOSING DATE - Friday 30th of October 2026 (COB).

Basic Qualification

• Minimum: Bachelor’s degree in biological, pharmaceutical or healthcare science.
• Proven experience in all phases of drug development in regulatory affairs and preferably in oncology.
• Experience with clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally
• Experience leading regional development, submission and approval activities in local region(s).
• Experience working effectively in matrix teams.
• Strong written and verbal communication skills for clarity and impact
• Strong experience of senior global stake-holder management.

Preferred Qualification

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

• Advanced scientific degree (PhD, MD, PharmD).
• Demonstrated ability to foster collaborative environments, proactively resolve challenges, and develop innovative solutions within regulatory constraints.
• Proficiency in digital fluency tools to enhance project delivery, efficiency, and innovation.

Skills

• Business Resilience
• Communication
• Digital Fluency
• Matrix Leadership
• Pharmaceutical Regulatory Compliance
• Regulatory Strategies
• Resource Management
• Stakeholder Management

Belgium Salary Range / Fourchette salariale - Belgique: EUR 98,250 to EUR 163,750 The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

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.

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 at [e-mail] where you can also request a call.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/