Vice President, Regulatory Affairs

Vice President, Regulatory AffairsAbout the CompanyWell-funded clinical-stage biotech companyIndustry BiotechnologyType Privately HeldAbout the RoleThe Company is seeking a Vice President of Regulatory Affairs to take on a pivotal role in the advancement of a pipeline of pulmonary therapeutics. The successful candidate will be responsible for developing and executing U.S. regulatory strategy across multiple development programs, with a focus on pulmonary indications. This includes leading and overseeing all regulatory submissions and interactions, serving as the primary contact with the FDA and other regulatory agencies, and building and evolving the regulatory function. The role demands a hands-on leader who can set regulatory strategy, manage regulatory infrastructure, and partner cross-functionally to identify and manage regulatory risks, timelines, and budgets.The ideal candidate will have a minimum of 15 years' of experience in regulatory affairs, with a strong preference for those with direct experience in the FDA's pulmonology division and a background in inhaled or respiratory products. Key responsibilities also include planning and leading agency meetings, as well as the potential to provide oversight of quality activities and external GMP/GCP partners. The role is well-suited for a senior leader who is both strategic and deeply involved in execution, and who is adept at building, mentoring, and leading teams. Strong regulatory judgment, communication skills, and the ability to operate under ambiguity are essential, as is the experience in managing CROs, consultants, and vendors.Travel Percent Less than 10%FunctionsBusiness Development