Vice President of Regulatory Affairs

Vice President of 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 play a pivotal role in the advancement of a pipeline of 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 hands-on leadership position involves setting regulatory strategy, serving as the primary point of contact with the FDA and other regulatory agencies, and building and evolving the regulatory function. The role is ideal for a senior leader who is both strategic and deeply involved in execution, and who thrives in a fast-moving, lean environment. Key responsibilities for the Vice President of Regulatory Affairs include leading and overseeing INDs, EOP interactions, NDA submissions, and responses to health authority inquiries. The ideal background includes 15+ years of regulatory affairs experience, with a strong preference for direct experience in the FDA's pulmonology/pulmonary division and a proven track record in small biotech environments. The candidate should have experience with inhaled or respiratory products, the ability to build and lead teams, and strong regulatory judgment. The role also requires the candidate to be adept at managing regulatory risk, timelines, and budgets, and to have the flexibility to work in a remote role with a high level of ownership.

Travel Percent
Less than 10%

Functions

• Operations