VP Regulatory Affairs

VP, Regulatory Affairs (Founding Regulatory Leader) - Ophthalmology / RetinaLocation: United States (Remote / Flexible) Reports to: Chief Medical Officer Stage: Clinical‑stage biotech with an active ophthalmology programAbout the OpportunityA well‑funded, clinical‑stage biotech in the ophthalmology space is seeking a founding VP of Regulatory Affairs to build and lead its global regulatory function. The company is advancing a novel retina‑focused therapeutic with clear clinical momentum and strong backing from experienced life sciences investors.This is a rare opportunity to join at the inflection point where strategic regulatory leadership directly influences clinical, CMC, and organizational direction. The role is ideal for a senior regulatory leader who wants to own the function, architect global strategy, and serve as a key partner in driving development for a first‑in‑class ophthalmic program.Key ResponsibilitiesDevelop and lead global regulatory strategy across U.S. and ex‑U.S. territories.Serve as the company's primary regulatory voice and strategic advisor across clinical, CMC, and nonclinical functions.Lead preparation of all major submissions, including IND amendments, briefing documents, meeting packages, and registration‑pathway deliverables.Drive all formal interactions with FDA, EMA, and other health authorities.Guide regulatory aspects of Phase 2 and Phase 3 development planning.Establish regulatory systems, documentation, and processes as the founding leader of the function.Manage external consultants and global regulatory partners.Qualifications10+ years of regulatory experience in biotechnology or pharmaceuticals.Demonstrated success in ophthalmology, ideally with retina‑focused programs.Experience supporting products through Phase 2 and Phase 3 clinical development.Expertise with both U.S. and ex‑U.S. (e.g., EMA) regulatory agencies.Ability to thrive in a fast‑moving, lean, collaborative environment.Strategic thinker who is also comfortable rolling up their sleeves as the first regulatory hire.What This Role OffersFounding ownership of the regulatory function.Ability to shape global development strategy for a promising retinal therapeutic.Close collaboration with an experienced executive and scientific leadership team.High visibility and influence in a company entering an important stage of growth.Competitive compensation, equity, and long‑term leadership opportunity.