Vice President of Regulatory Affairs

Vice President of Regulatory Affairs

About the Company

Well-funded clinical-stage biotech advancing 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 pivotal role as the founding regulatory leader. This senior position is focused on building and leading the global regulatory function for a novel retina-focused therapeutic. The successful candidate will be responsible for developing and leading the global regulatory strategy, serving as the primary regulatory voice and strategic advisor across various functions, and leading the preparation of all major regulatory submissions. This includes driving interactions with regulatory agencies such as the FDA and EMA, and guiding the regulatory aspects of clinical development planning. The role demands a strategic thinker with a hands-on approach, capable of establishing regulatory systems and processes, and managing external consultants and global regulatory partners. Applicants for the VP of Regulatory Affairs role 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 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. The role requires the ability to thrive in a fast-paced, collaborative environment and offers the opportunity to shape the global development strategy for a promising retinal therapeutic. The company is seeking a leader who is ready to take on a high-visibility, influential position in a company that is entering a significant growth stage.

Hiring Manager Title
Chief Medical Officer

Functions

• Operations