Vice President, Regulatory Affairs

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 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%

Functions

• Business Development