Director, Global Regulatory Affairs Lead (Oncology)
GSK
USA - Pennsylvania - Upper ProvidencePosted Discovered via the company's careers siteMatch locked
Full time3+ years exp
About the role
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
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- 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
If you have the following characteristics, it would be a plus:
- 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.
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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Not included in the source posting: about the role, benefits.
Skills
artificial-intelligence
Who can apply
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