Director Global Regulatory Strategy, Oncology

GSK • Waltham, PA

1d • Hybrid

About The Position

The Director, Global Regulatory Strategy—Oncology develops and executes regulatory strategies for assigned assets in alignment with medicine development and integrated evidence strategies. The role helps ensure development programs address priority market needs and target medicine profiles while meeting applicable regulatory requirements and GSK policies and processes. It may include direct or indirect people leadership and may include Global Regulatory Lead responsibilities for one or more assets.

The Director provides regulatory leadership for assigned programs, including evaluating regulatory precedent, intelligence, competitive landscape, and implications for asset strategy. The role works across development teams, local regulatory teams, commercial partners, health authorities, and other stakeholders to support regulatory strategy, review processes, and labeling objectives consistent with available data. It serves as an accountability point for assigned regulatory work packages and contributes to Regulatory Matrix Team activities as applicable.

The position also supports due diligence, business development, and portfolio assessments as needed; ensures regulatory work complies with applicable laws, regulations, internal policies, and GSK expectations; and communicates strategy, risks, options, and recommendations to senior leaders and cross-functional partners. Where people leadership is part of the role, responsibilities include developing team members, workforce and resource planning, and building effective, inclusive teams. The role is hybrid in the United States, with regular onsite attendance for leadership activities and key meetings; remote-first US candidates may be considered if able to travel as needed.

Requirements

• Bachelor's degree in biology, life sciences, healthcare sciences, pharmaceutical sciences, regulatory science, or a related scientific discipline.
• At least 8 years of Regulatory Affairs experience in the pharmaceutical, biotechnology, or healthcare industry.
• At least 6 years of experience supporting drug development programs spanning multiple phases of clinical development.
• At least 3 years of experience developing and executing global regulatory strategies for investigational or marketed oncology products.
• Experience leading health authority interactions, including preparation, execution, and follow-up for 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, intelligence, and evolving requirements to development or lifecycle management programs.
• Experience supporting regulatory activities in major global markets, including the United States, European Union, or other international 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.

Nice To Haves

• Advanced degree (MS, PharmD, PhD, MD, or equivalent) in a scientific discipline.
• At least 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.

Responsibilities

• Develop and execute regulatory strategies for assigned assets, aligning them with development plans, integrated evidence strategies, priority market needs, and regulatory requirements.
• Provide regulatory leadership, assessing regulatory precedent, intelligence, the competitive landscape, and potential impacts on asset strategy.
• Lead, coordinate, or contribute to health authority interactions and regulatory review processes for assigned programs.
• Work with Early Development Teams, Medicine Development Teams, local regulatory teams, commercial partners, and cross-functional stakeholders on regulatory strategy and labeling objectives consistent with available data.
• Be accountable for assigned regulatory work packages and lead or contribute to Regulatory Matrix Team activities, as applicable.
• Ensure regulatory activities comply with applicable laws, regulations, internal policies, and GSK expectations.
• Provide regulatory input into due diligence, business development, licensing, or portfolio-level assessments as needed.
• If applicable, manage and develop direct or indirect team members, support workforce planning and resource management, and help build effective, inclusive teams.
• Partner with senior stakeholders on program strategy, resource planning, operating model development, and longer-term objectives or large-scale initiatives.
• Communicate regulatory strategy, risks, options, and recommendations to senior leaders, health authorities, and cross-functional partners.

Benefits

• Annual bonus
• Eligibility to participate in a share-based long-term incentive program, dependent on role level
• Health care and other insurance benefits for employees and families
• Retirement benefits
• Paid holidays
• Vacation
• Paid caregiver, parental, and medical leave

What This Job Offers

• Job Type: Full-time
• Career Level: Director