Vice President, Global Regulatory Affairs Strategy - Cambridge - 1925 GlaxoSmithKline LLC

    1925 GlaxoSmithKline LLC
    1925 GlaxoSmithKline LLC Cambridge

    17 hours ago

    Full time
    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.
    Find out more:

    Position Summary

    In this critical leadership role, the VP Global Regulatory Strategy RI&I will oversee regulatory strategy globally for the RI&I portfolio, including the associated communication strategy to all regulatory authorities. Moreover, the VP will act as a direct link between Regulatory Affairs and all RI&I R&D stakeholders and provide the regulatory input to Governance decisions for clinical/project regulatory matters. They will also serve as a senior leader and the responsible head who ensures appropriate regulatory compliance in the conduct of global development programs and product lifecycle maintenance and license to operate activities for the RI&I portfolio. This role will be a member of the Global Regulatory Strategy LT as well as leading the GRS RI&I team of approximately 60 FTEs.

    Key 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.

    • Why You?

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

  • 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 Qualification
    If you have the following characteristics, it would be a plus

  • 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.

    • • 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 $315,750 to $526,250.

    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.

    Please visit 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 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.

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