Director, Global Regulatory Affairs Lead (Oncology)

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 210,000 - 260,000; Full time

Job summary

GlaxoSmithKline seeks a Director of Global Regulatory Strategy- Oncology to develop and execute regulatory strategies for oncology assets, aligning with development plans and evidence strategies. You may lead teams and be accountable for regulatory work packages across assets.

You will collaborate with Early Development, Medicine Development, and cross-functional partners, guiding interactions with health authorities and ensuring compliance with internal policies.

Qualifications

• Bachelor's degree in biology, life sciences, healthcare sciences, pharmacology, regulatory science, or related field.
• 8+ years in Regulatory Affairs within pharma/biotech/healthcare.
• 6+ years supporting drug development across multiple phases.
• 3+ years developing global regulatory strategies for oncology assets.
• Experience leading Health Authority interactions.
• Experience cross-functional development teams.

Responsibilities

• Lead or oversee regulatory strategies for assigned assets.
• Provide regulatory leadership with assessment of regulatory precedent and intelligence.
• Lead, coordinate, or contribute to health authority interactions.
• Support regulatory strategy and labeling objectives with cross-functional teams.
• Ensure regulatory activities comply with laws, regulations, and internal policies.

Skills

Regulatory strategy

Regulatory leadership

Cross-functional leadership

Health Authority interactions

Lifecycle regulatory compliance

Education

Bachelor's degree in biology / life sciences

Advanced degree in life sciences (MS/PhD/MD)

Job description

Position Summary

The Director, Global Regulatory Strategy- Oncology is responsible for developing and executing regulatory strategies for assigned assets in alignment with medicine development and integrated evidence strategies. This role helps ensure development programs support priority market needs, target medicine profiles, applicable regulatory requirements, and internal GSK policies and processes. The role may include direct or indirect people leadership and may also include Global Regulatory Lead responsibilities for one or more assigned assets.

Key Responsibilities

• Lead or oversee the development and execution of regulatory strategies for assigned assets, ensuring alignment with development plans, integrated evidence strategies, priority market needs, and applicable regulatory requirements.
• Provide regulatory leadership for assigned programs, including assessment of regulatory precedent, regulatory intelligence, competitive landscape, and potential impact on asset strategy.
• Lead, coordinate, or contribute to interactions with health authorities and regulatory review processes, as applicable to assigned programs.
• Work with Early Development Teams, Medicine Development Teams, local regulatory teams, commercial partners, and other cross‑functional stakeholders to support regulatory strategy and labeling objectives that are consistent with available data.
• Serve as a point of accountability for assigned regulatory work packages and lead or contribute to Regulatory Matrix Team activities, as applicable.
• Ensure regulatory activities are conducted in accordance with applicable laws, regulations, internal policies, and GSK expectations.
• Provide regulatory input into due diligence, business development, or portfolio‑level assessments, as needed.
• Where the role includes people leadership, manage and develop direct or indirect team members, support workforce planning, contribute to resource management, and help build effective, inclusive teams.
• Partner with senior stakeholders to support program‑level strategy, resource planning, operating model development, and delivery of longer‑term objectives or large‑scale initiatives.
• Communicate regulatory strategy, risks, options, and recommendations clearly to senior leaders, health authorities, and cross‑functional partners.

Why You?

Work arrangement: Hybrid, with regular presence at a US site for leadership activities and key meetings. Remote‑first candidates may be considered if located in the United States and able to travel as required.

Basic Qualification

• Bachelor's degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline.
• 8+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry.
• 6+ years of experience supporting drug development programs spanning multiple phases of clinical development.
• 3+ years of experience developing and executing global regulatory strategies for investigational or marketed products in Oncology.
• Experience leading Health Authority interactions, including preparation, execution, and follow‑up activities related to regulatory milestone meetings.
• Experience working on cross‑functional development teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions.
• Experience assessing and applying regulatory precedent, regulatory intelligence, and evolving regulatory requirements to development or lifecycle management programs.
• Experience supporting regulatory activities in major global markets, including the United States, European Union, or other international regulatory jurisdictions.
• Experience influencing senior stakeholders and providing strategic regulatory recommendations in a matrix environment.
• Demonstrated experience ensuring compliance with applicable regulatory requirements, industry standards, and company policies throughout the product lifecycle.

Preferred Qualification

• Advanced degree (MS, PharmD, PhD, MD, or equivalent) in a scientific discipline.
• 10+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
• Experience supporting business development, licensing, acquisitions, or due diligence activities.
• Experience leading regulatory activities across multiple geographic regions.
• Experience managing regulatory professionals in a global matrix environment.
• Experience incorporating digital, AI‑enabled, or data‑driven approaches into regulatory strategy or decision‑making.

Skills

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

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail].

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements.

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We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where they feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.