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Director US Regulatory Policy
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GSK
Washington Dc, Dist. Columbia, United States
(on-site)
Director US Regulatory Policy
Share Print
GSK
Washington Dc, Dist. Columbia, United States
(on-site)
Posted 5 hours ago
Director US Regulatory Policy
Share Print
GSK
Washington Dc, Dist. Columbia, United States
(on-site)
Job Type
Full-Time
Job Function
Other
Director US Regulatory Policy
The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.
Director US Regulatory Policy
The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.
Description
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 people's 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. We're uniting science, technology, and talent to get ahead of disease together.
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Our approach to R&D
Position Summary
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.
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 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.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- 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
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
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.
- 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 $171,600 to $286,000.
- If you are based in another US location, the annual base salary range is $156,000 to $260,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In 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.
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 we're 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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
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.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
Job ID: 84844501
GSK
Websitewww.gsk.com US Headquarters: Philadelphia, PA Size:10000 employees Founded: 1830 Type: Company - Public (GSK) Industry: Biotech & Pharmaceuticals Revenue: $10 billion (USD) per year Video: https://youtu.be/RBdgq5VTQmM We are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We also have a significant global presence with commercial operations in more than 150 countries, a netwo...
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5473 Blair Rd Ste 100, PMB 592231 Dallas, Texas 75231
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Washington Dc, Dist. Columbia, United States
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Salary : $156,000 - $260,000