GSK · 16 hours ago
Vice President, Global Regulatory Affairs Strategy - RI&I
USA - Massachusetts - Cambridge
Full-time
Hybrid
Director/Executive
$316K/yr - $526K/yrGSK is a global biopharma company with ambitions to positively impact the health of 2.5 billion people by the end of the decade. The VP Global Regulatory Strategy RI&I will oversee regulatory strategy globally for the RI&I portfolio, ensuring compliance and effective communication with regulatory authorities while leading a team of approximately 60 professionals.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Directly accountable for global regulatory development and filings for the RI&I portfolio of products
Ensures that sound regulatory practices are fully integrated into pre-clinical, clinical and technical submissions, and that all documents submitted to regulatory agencies are appropriately reviewed to ascertain they are complete, scientifically accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review
Contributes to the creation and implementation of development plans that incorporate regulatory strategies designed to maximise the likelihood of successful regulatory applications, delivering regulatory approval, key labeling claims and reimbursement for all key indications
Exhibits leadership in the formulation and execution of global regulatory strategies and contributes to the development and implementation of policies and strategies for optimisation of development, lifecycle maintenance and license to operate
Monitors and anticipates regulatory, scientific and pertinent legal issues and assesses potential impact on GSK; advises senior management on events of significance to GSK’s business interests; proactively influences changes in guidelines and regulation to strengthen the regulatory review process and ensure core operations are proactively aligned with emerging policies
Develops and maintains excellent working relationships with FDA, EMA, PMDA and CFDA and other key international regulatory agencies, overseeing the planning and implementation of agency meetings, as appropriate; assuring collaborative approaches to product development and clinical plans with agencies via scientific advice and protocol assessment procedures
Provides leadership to assure appropriate regulatory compliance in the conduct and reporting of clinical trials, institutionalise policies and procedures and track performance
Attracts, develops and retains key regulatory professionals, recognised for their strategic focus and regulatory and scientific acumen in alignment with the principles of Project First, Expert Led, and Tech Enabled
Represents Global Regulatory Affairs for RI&I on senior level decision making bodies
Acts as a credible, influential, respected spokesperson during interactions with international regulatory agencies and external organisations, and ensures appropriate, proactive communication with agencies to assure expedient and efficient review and approval of submissions
Serves as an external proactive industry leader and influential spokesperson in support of GSK enterprise priorities and regulatory initiatives, and in shaping the external environment
Serves as the senior regulatory input to RI&I R&D stakeholders and senior level governance boards
Drives the GSK innovation culture including proactive individual and team adoption of the importance of digitalisation in development and regulatory decision making
Qualification
Required
Bachelors degree in Pharmacology, Immunology, Biology
Experience leading the development of regulatory strategy within development programs; Experience working in early phase and late phase development projects as well as life-cycle
People management and project leadership skills
Regulatory affairs/product development experience of which a significant part has been in a senior role
Experience of collaboration with the FDA/EMEA/significant agencies and evidence of success in gaining product approvals and defending established products
Preferred
PhD or MD
Ability to interact to affect direction and decision making within development programs
Ability to multi task and excel in cross functional settings and to manage multiple projects in a fast-paced environment
Gravitas to negotiate within a highly matrixed environment to deliver complex messages and facilitate appropriate team decisions
Ability to provide operational oversight and support project teams in strategic decisions and guide them through diverse and conflicting regulatory requirements
Ability to assess situations, organizations and processes to identify opportunities for improvement and simplification and then to plan and articulate solutions (with appropriate team and stakeholder support)
Experience of presenting to senior levels with good influencing skills to ensure that the GRA voice is clearly articulated and heard in both internal and external audiences
Ability to read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquiries or complaints
Demonstrated strategic capability, ability to see the overall ‘big' picture; Insightful and forward thinking, ability to recognize, anticipate and review/discuss potential regulatory challenges with teams, and present management with recommendations that reflect full consideration of available options
Evidence of proactive leadership to identify issues and mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
Ability to work with remote teams/individuals and manage these teams through influencing skills while exhibiting sensitivity to and an understanding of different working styles
Advanced knowledge of drug development process and laws and regulations affecting the pharmaceutical industry in key jurisdictions, particularly US and European regulations
Strategic and enterprise thinker – ability to connect different elements together
Culturally aware and experience in working with varying cultures and in matrix team environment
Recognized excellent communication skills, both oral and written
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
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
Founded in 1929
10001+ employees
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 CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
2026-01-16
2026-01-13
South China Morning Post
2026-01-08
Company data provided by crunchbase