Vice President of Regulatory Affairs, Founding Regulatory Leader, Ophthalmology & Retina

Confidential

Denver, CO

Vice President of Regulatory Affairs, Founding Regulatory Leader, Ophthalmology & Retina

About the Company

Well-funded clinical-stage biotech in ophthalmology developing a novel retina-focused therapeutic.

Industry
Biotechnology

Type
Privately Held, VC-backed

About the Role

The Company is in search of a VP of Regulatory Affairs to take on a founding role in building and leading its global regulatory function. This senior leadership position is pivotal, as the successful candidate will be responsible for developing and executing the global regulatory strategy, serving as the primary regulatory voice and strategic advisor across various functions, and leading all major regulatory submissions and interactions with health authorities. The role demands a professional with over 10 years' of regulatory experience in the biotechnology or pharmaceutical industry, with a proven track record in ophthalmology, particularly in retina-focused programs. The ideal candidate will have experience in supporting products through Phase 2 and Phase 3 clinical development, and possess expertise in both U.S. and ex-U.S. regulatory agencies. As the founding VP of Regulatory Affairs, the role offers the opportunity to shape the global development strategy for a promising retinal therapeutic and to establish regulatory systems, documentation, and processes. The candidate should be a strategic thinker, capable of influencing clinical, CMC, and organizational direction, and be comfortable in a hands-on role as the first regulatory hire. The position is suited to a professional who can thrive in a fast-moving, lean, and collaborative environment, and who is ready to take on the challenge of driving the development of a first-in-class ophthalmic program. The role is highly visible and influential, with close collaboration expected with an experienced executive and scientific leadership team.

Hiring Manager Title
Chief Medical Officer

Functions

Medical Care/Hospital Administration

Confidential

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Vacancy posted 5 days ago

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