Vice President, Regulatory Affairs

About the Company

Well-funded clinical-stage biotech company

Industry
Biotechnology

Type
Privately Held

About the Role

The 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 id...