Vice President of Regulatory Affairs
Confidential
Vice President of Regulatory Affairs
About the Company
Well-funded clinical-stage biotech developing a retina-focused ophthalmology 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 strategic thinker with a hands-on approach, capable of establishing regulatory systems and processes, and managing external consultants and global regulatory partners. The ideal candidate will have a minimum of 10 years' regulatory experience in biotechnology or pharmaceuticals, with a proven track record in ophthalmology, particularly in retina-focused programs, and experience in supporting products through Phase 2 and Phase 3 clinical development. Applicants for the VP of Regulatory Affairs position at the company should possess a strong background in regulatory affairs, with a focus on ophthalmology and retina programs. The role requires expertise in both U.S. and ex-U.S. regulatory agencies, particularly the FDA and EMA. The candidate must be adept at guiding regulatory aspects of clinical development planning and be prepared to take on the challenge of being the first regulatory hire, with the opportunity to shape the function and global development strategy. A collaborative and fast-paced work environment is expected, and the role offers the chance to work closely with an experienced executive and scientific leadership team. The successful candidate will have a high level of visibility and influence in the company, with a long-term leadership opportunity.
Hiring Manager Title
Chief Medical Officer
Functions
- Operations
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