EPM Scientific are partnering with a well‑funded, clinical‑stage biotech to identify a senior Regulatory Affairs leader to build and lead the regulatory function as the company advances a pipeline of pulmonary therapeutics toward late‑stage development and commercialization. This is a rare opportunity to step into a high‑impact, hands‑on leadership role within a small, nimble organization where regulatory strategy and execution are central to company success. The OpportunityIn this role, you will wear many hats-setting regulatory strategy, serving as the FDA point of contact, and building scalable regulatory (and potentially quality) infrastructure. You will work closely with clinical, CMC, and development partners to move programs efficiently through Phase 1-3 and toward registration.This position is ideal for a senior leader who enjoys being both strategic and deeply involved in execution, and who thrives in lean, fast‑moving environments.

Key Responsibilities

Develop and execute U.S. regulatory strategy across multiple development programs, with an emphasis on pulmonary indications Lead and oversee INDs, EOP interactions, NDA submissions, and responses to Health Authority inquiriesServe as the primary point of contact with the FDA and other regulatory agencies Plan, prepare, and lead agency meetings (Type A/B/C) Build and evolve the regulatory function from an outsourced model; manage CROs, consultants, and vendors Establish and maintain phase‑appropriate SOPs, processes, and regulatory infrastructure Partner cross‑functionally to identify and manage regulatory risk, timelines, and budgets Depending on background, provide oversight of quality activities and external GMP/GCP partners Ideal Background 15+ years of Regulatory Affairs experience across all stages of drug development Direct experience interacting with the FDA's pulmonology/pulmonary division strongly preferred Track record of leading IND and NDA‑stage programs in small biotech environments Experience with inhaled or respiratory products is highly desirable Demonstrated ability to build, mentor, and lead teams while remaining hands‑on Strong regulatory judgment, communication skills, and comfort operating under ambiguity Prior CRO experience or extensive vendor oversight is a plus If you're a senior regulatory leader looking to make a visible, lasting impact-and want the flexibility of a remote role with meaningful ownership-I'd welcome a confidential conversation.