Director US Regulatory Policy

Business Introduction
At GSK we have bold ambitions for patients aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform peoples lives. GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. Were uniting science technology and talent to get ahead of disease together.
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Position Summary

This role leads US regulatory policy and advocacy efforts to support the advancement and lifecycle management of GSKs 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.

Key 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 GSKs 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.

Why You

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelors 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

Preferred Qualification
If you have the following characteristics it would be a plus:

• 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

Work arrangement
This role is hybrid. Regular on-site collaboration is expected. Typical schedule will be two to three days on-site per week.

What we value in you
You are collaborative curious and accountable. You make clear recommendations and balance scientific regulatory and commercial considerations. You enjoy building trusted relationships and influencing complex decisions. You welcome different perspectives and help create an inclusive environment where everyone can do their best work.

Ready to make a difference
If this role matches your experience and ambitions we encourage you to apply. Tell us how you will shape US regulatory policy and help improve outcomes for people.

Skills

Business Resilience Communication Digital Fluency Matrix Leadership Pharmaceutical Regulatory Compliance Policy Advocacy Regulatory Strategies Resource Management Stakeholder Management

If you are based in Cambridge MA; Waltham MA; Rockville MD; or San Francisco CA the annual base salary for new hires in this position ranges $171600 to $286000. If you are based in another US location the annual base salary range is $156000 to $260000. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the addition this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country the relevant compensation will be discussed during the recruitment process.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK

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 were 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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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

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