Sr. Director/Director Biopharm CMC Strategy, Policy and Advocacy jobs in United States
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GSK · 2 hours ago

Sr. Director/Director Biopharm CMC Strategy, Policy and Advocacy

positionWashington DC
timeFull-time
remoteOnsite
seniorityDirector/Executive
money$194K/yr - $322K/yr
date10+ years exp

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. They are seeking a highly experienced Sr. Director/Director of CMC Regulatory Policy and Advocacy to shape and influence regulatory policies related to Chemistry, Manufacturing, and Controls on a global scale, with a focus on supporting digital, devices, and sustainability priorities.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Develop and implement CMC regulatory strategies to influence CMC policies and guidelines, with a focus on the US
Engage with regulatory agencies, industry groups, and other stakeholders to advocate for a CMC regulatory environment enabling innovation and patient access
Monitor and analyze CMC trends, providing strategic CMC regulatory insights to internal teams
Lead cross-functional business teams to ensure compliance with global CMC regulatory requirements and implement innovative CMC strategies
Represent the company in industry forums, conferences, and regulatory meetings
Collaborate with internal departments to align CMC regulatory strategies with business objectives and delivery of the innovative medicines pipeline

Qualification

CMC regulatory policyBiopharmaceutical industry experienceGlobal CMC regulatory knowledgeAdvanced scientific degreeAdvocacy skillsCommunication skillsNegotiation skillsRelationship buildingStrategic thinking

Required

Advanced degree in a scientific discipline (Ph.D., Pharm.D., or equivalent preferred)
Minimum of 10 (12+ for Sr Director) years of experience of CMC within the biopharmaceutical industry

Preferred

Strong knowledge of global CMC regulatory requirements and guidelines
Excellent communication, negotiation, and advocacy skills
Proven ability to build and maintain relationships with regulatory authorities and industry stakeholders
Experience of developing a policy and intelligence network, with a focus on the US
Strategic thinker with the ability to influence and drive CMC regulatory policy changes

Benefits

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Company

GSK

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We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
dateFounded in 1929
location
London, England, GBR
people-size10001+ employees
web-link
http://www.gsk.com

H1B Sponsorship

GSK has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)

Funding

Current Stage
Public Company
Total Funding
$25.51M
Key Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO

Leadership Team

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Julie Brown
CFO
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Mike Elmore
SVP & Chief Information Security Officer, GSK
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Recent News

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2026-01-16
AP News
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2026-01-13
South China Morning Post
Chinese drug makers strike a record US$136 billion in out-licensing deals in 2025
2026-01-08
Company data provided by crunchbase