Site Name: USA - Massachusetts - Cambridge, Baar Onyx, Belgium-Wavre, GSK HQ, USA - Pennsylvania - Upper Providence Posted Date: Feb 14 2025 The Vice President, Global Regulatory, Vaccines will facilitate GSK's objectives via the development and implementation of innovative regulatory strategies, to ensure our ability to successfully take Vaccines from the discovery and early development, through regulatory approval, optimal reimbursement and launch and life cycle commercialization and maintenance. In this critical leadership role you will oversee regulatory strategy and submissions globally for the Vaccines portfolio, including the associated communication strategy to all regulatory authorities. In this role you will act as a direct link between Regulatory Affairs and Vaccines R&D and provide the regulatory input to Governance decisions for clinical/project regulatory matters and serve as a senior internal leader and the responsible head that ensures appropriate regulatory compliance in the conduct of global development programs and product life cycle maintenance and license to operate activities for the Vaccines portfolio. Some of your key responsibilities will include: Directly accountable for global regulatory development and filings for the Vaccines 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 maximize the likelihood of successful regulatory applications, delivering regulatory approval 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 optimization of drug/vaccine development, life-cycle maintenance and license to operate Monitors and anticipates regulatory, scientific and pertinent legal issues and assesses potential impact on the Company; advises senior management on events of significance to the Company’s business interests; 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, institutionalize policies and procedures and track performance Attracts, develops and retains key regulatory professionals, recognized for their customer focus and regulatory and scientific acumen Represents Global regulatory Affairs for Vaccines on senior level decision making bodies Acts as a credible, influential, respected spokesperson during interactions with international regulatory agencies and external organizations, and ensures appropriate, proactive communication with agencies to assure expedient and efficient review and approval of submissions Serves as an external industry leader and influential spokesperson in support of company global regulatory initiatives. Serves as the senior regulatory input to Vaccines R&D and senior level governance boards Basic Experience required: Bachelors degree in Pharmacology, Immunology, Biology Experience leading the development of regulatory strategy and interacting to affect direction and decision making within development programs; Experience working in early phase and late phase development projects as well as life-cycle People management and project leadership skills, ability to provide operational oversight and support project teams in strategic decisions and guide them through diverse and conflicting regulatory requirements 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 Experience: 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. 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 special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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. 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