Director, Regulatory Strategy

Job DescriptionGeneral Summary:The Director, Regulatory Strategy will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within the Vertex portfolio. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective integration of broad regulatory ideas/tactics supporting program strategy. This roles assignments may be global, regional or local depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy.Key Duties and Responsibilities:Leads the development of regulatory strategy for assigned projects/regions in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy DocumentsRepresents GRA on core development functional teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategyAddresses complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams, GRA functional team and GRA leadershipAnticipates global regulatory changes and develops proactive strategy accordinglyShapes the regulatory strategy for regulatory submission documents and Health Authority communicationsCounsels and advises GRA leadership on status of global Regulatory Affairs strategies and tactics, procedures and practicesEnsures the global regulatory strategy for a given project is consistent with the business objectives and is compliant with current regulations and guidanceManages project plans and timelines to ensure all projects are appropriately prioritized and key goals are met on timeContributes to the continuous improvement of existing department processes and strategies, providing recommendations in area of expertiseProvides regulatory leadership to the GRA functional team(s) in context of participating in the skill development, coaching, and performance feedback for members of the GRA functional teamsAs a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.Knowledge and Skills:Advanced technical skill in regulatory affairs science including knowledge of regulatory frameworks and external environments. Advanced knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use.Advanced knowledge of the research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticalsProficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products.Proficient skills in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well organized preparation of cross functional teams.Advanced skill in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development.Actively uses expertise to develop others by providing coaching, guidance and mentoring.A strong collaborative partner with cross functional colleagues with the ability to build consensus through ability to present a clear and compelling case for ideasDemonstrates excellent communication skills with ability to impact and influence the decisions of a teamEducation and Experience:Bachelor's degree in Biology, Chemistry, or other related disciplineTypically requires 10 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 3 years of supervisory/management experience, or the equivalent combination of education and experienceWe’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:1. Hybrid and work remotely up to two days per week; or select2. On-Site and work 5 days per week with ad hoc flexibility.