Senior Director, Global Regulatory Strategy- Oncology

GSK•Upper Providence, PA

3d•$222,000 - $370,000•Hybrid

About The Position

The Senior 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.

Requirements

Bachelor's degree in Biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline.
10+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry.
7+ years of experience supporting drug development programs spanning multiple phases of clinical development.
5+ years of experience developing and executing global regulatory strategies for investigational or marketed products in Oncology
Experience leading or serving as the regulatory lead for at least one major regulatory submission, approval, or significant lifecycle management submission with a Health Authority.
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.

Nice To Haves

Advanced degree (MS, PharmD, PhD, MD, or equivalent) in a scientific discipline.
12+ 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

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 portfolio-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.