Director US Regulatory Policy

GSK•Rockville, MD

22h•$156,000 - $286,000•Hybrid

About The Position

This role leads US regulatory policy and advocacy efforts to support the advancement and lifecycle management of GSK’s biopharmaceutical portfolio. The position plays a critical role in shaping the evolving US regulatory environment by influencing key policy decisions and ensuring GSK is well-positioned to anticipate and respond to regulatory change. Working across global and US-based teams, this role develops science-driven policy strategies, engages with regulatory agencies and external stakeholders, and supports enterprise-level advocacy priorities. The role offers strong visibility, professional growth, and the change to make a meaningful impact for patients and GSK.

Requirements

Bachelor’s degree in life sciences, public policy, law, or a related field
10+ years of experience in regulatory affairs/policy across the full medicines development lifecycle
Demonstrated experience in regulatory policy and advocacy within the US regulatory environment

Nice To Haves

Advanced degree (JD, MS, MPH, PharmD, or PhD) in a relevant discipline
Experience leading policy development on complex regulatory topics such as clinical trials, product approvals, or lifecycle requirements
Prior experience engaging with US regulatory agencies, government bodies, and industry/trade associations
Experience leading cross-functional, matrixed teams across global regions
Strong ability to analyze complex regulatory information and communicate insights clearly and succinctly
Broad understanding of the US regulatory landscape, including key agencies and policymaking processes
Proven track record influencing regulatory policy and building coalitions within industry or public policy forums
Familiarity with regulatory policies around emerging technologies such as AI/ML, cloud-based submission platforms, & digital health
Experience within oncology therapeutic policy frameworks

Responsibilities

Provide interpretation and advice on new US legislation, guidelines and policies for assigned topics in support of GSK biopharmaceutical portfolio.
Collaborate with internal teams to develop and execute regulatory policy strategies in the US.
Support GSK’s strategy for US engagement and maintain links with key external stakeholders and networks including regulatory agencies and trade associations.
Interact with key regulatory agencies, governments and trade associations on assigned topic areas.
Represent GSK and/or trade associations at key Agency, Industry, and trade association meetings.
Liaise with other GRPI staff, US public policy and government affairs staff, R&D functions, and other internal stakeholders to support development of aligned GSK positions.
Lead global regulatory policy and advocacy strategy for select enterprise-level policy priorities.
Lead asset-specific global regulatory policy and advocacy strategy for select priority assets and in select priority markets.
Support responses to regulatory intelligence queries from R&D partners.