Director, Global Regulatory Affairs Lead (Oncology)

Biopharma Careers; Upper Providence (Delaware County); Hybrid; USD 180,000 - 240,000; Full time

Job summary

GSK is seeking a Director, Global Regulatory Strategy - Oncology to develop and execute regulatory plans for oncology assets, ensuring alignment with development strategies and market requirements. The role includes leadership of regulatory teams and cross-functional collaboration with clinical, safety, and commercial functions.

The position requires extensive experience in regulatory affairs, including interactions with health authorities, and a track record of strategic regulatory

Qualifications

• Bachelor's degree in biology, life sciences, healthcare sciences, pharmaceutical sciences, regulatory science, or related discipline.
• 8+ years of experience in Regulatory Affairs within pharma/biotech/healthcare.
• 6+ years of experience supporting drug development in multiple phases.
• 3+ years developing and executing global regulatory strategies in Oncology.
• Experience leading Health Authority interactions and regulatory milestones.
• Experience cross-functional development teams (Clinical, Safety, Commercial, Statistics, CMC, R&D).
• Experience applying regulatory precedent and intelligence to programs.
• Experience supporting regulatory activities in major global markets (US, EU, others).
• Experience influencing senior stakeholders in a matrix environment.

Responsibilities

• Lead or oversee development and execution of regulatory strategies for assets.
• Provide regulatory leadership including assessment of precedent and competitive landscape.
• Lead or contribute to interactions with health authorities and regulatory review processes.
• Collaborate with Early Development, Medicine Development, local regulatory teams, and partners.
• Accountable for regulatory work packages and participate in Regulatory Matrix Team activities.
• Ensure activities comply with laws, regulations, and internal policies.
• Contribute regulatory input to due diligence and portfolio assessments.
• Mentor and develop team members and support resource planning.
• Partner with senior stakeholders on program strategy and long-term objectives.
• Clearly communicate strategy, risks, and recommendations to senior leaders and cross-functional partners.

Skills

Business resilience

Communication

Digital fluency

Matrix leadership

Pharmaceutical regulatory compliance

Regulatory strategies

Resource management

Stakeholder management

Education

Bachelor's degree in biology/life sciences/related

Advanced degree (MS/PhD/MDS/PharmD) preferred

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.

#Li-GSK

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.

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