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.