Vice President of Regulatory Affairs

Vice President of Regulatory Affairs

About the Company

Well-funded, clinical-stage biotech advancing a novel retina-focused therapeutic with strong investor backing.

Industry
Biotechnology

Type
Privately Held, VC-backed

About the Role

The Company is in search of a Vice President of Regulatory Affairs to establish and lead its global regulatory function. This pivotal role involves 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 successful candidate will be responsible for guiding the regulatory aspects of the company's clinical development, particularly in the Phase 2 and Phase 3 stages, and will be instrumental in shaping the global development strategy for a novel retina-focused therapeutic. As the founding leader of the regulatory function, the VP will also be tasked with establishing regulatory systems, documentation, and processes, and managing external consultants and global regulatory partners. Applicants for the VP of Regulatory Affairs position at the company should have a minimum of 10 years' regulatory experience in the biotechnology or pharmaceutical industry, with a proven track record in ophthalmology, particularly with retina-focused programs. The role requires expertise in both U.S. and ex-U.S. regulatory agencies, and the ability to thrive in a fast-paced, collaborative environment. The ideal candidate will be a strategic thinker, capable of both high-level planning and hands-on execution, and will play a key role in the company's growth and development. This is a unique opportunity for a senior regulatory leader to make a significant impact and to be part of a team that is at the forefront of advancing a promising therapeutic.

Functions

• Operations