Vice President Regulatory Affairs

Head of Regulatory Affairs (Pulmonary Therapeutics)
Remote - United States | Occasional Travel
Compensation: $300,000-$385,000 base + equity/bonus potential

I'm 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 Opportunity
In 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 inquiries
Serve 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.