VP Regulatory Affairs
VP, Regulatory Affairs (Founding Regulatory Leader) - Ophthalmology / Retina
Location: United States (Remote / Flexible)
Reports to: Chief Medical Officer
Stage: Clinical‑stage biotech with an active ophthalmology program
About the Opportunity
A 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 Responsibilities
- Develop 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.
Qualifications
- 10+ 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 Offers
- Founding 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.
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