Director Global Regulatory Strategy, Oncology

GSK • Rockville, MD

2d • $171,750 - $286,250 • 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 support priority market needs, target medicine profiles, applicable regulatory requirements, and internal GSK policies and processes. Responsibilities may include direct or indirect people leadership and Global Regulatory Lead responsibilities for one or more assigned assets.

This hybrid role is based in the United States, with regular on-site presence for leadership activities and key meetings. Remote-first candidates located in the United States may be considered if they can travel as required. The position partners with cross-functional teams and senior stakeholders to shape program strategy, support regulatory interactions, and communicate risks, options, and recommendations.

For new hires based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary range is $171,750 to $286,250. The position also offers an annual bonus and eligibility to participate in a share-based long-term incentive program, dependent on role level. Benefits include health care and other insurance for employees and family, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

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, 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 making strategic regulatory recommendations in a matrix environment.
• Demonstrated experience ensuring compliance with 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

• Lead or oversee development and execution of regulatory strategies for assigned assets, aligned with development plans, integrated evidence strategies, priority market needs, and applicable regulatory requirements.
• Provide regulatory leadership for assigned programs, assessing regulatory precedent, regulatory intelligence, the competitive landscape, and potential effects on asset strategy.
• Lead, coordinate, or contribute to health authority interactions and regulatory review processes, as applicable.
• Work with Early Development Teams, Medicine Development Teams, local regulatory teams, commercial partners, and other cross-functional stakeholders to support regulatory strategy and data-consistent labeling objectives.
• Serve as an accountability point 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 to due diligence, business development, or portfolio-level assessments, as needed.
• Where people leadership is part of the role, 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-level 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, depending on role level
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Paid caregiver/parental and medical leave

What This Job Offers

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