Job Description
Vice President, Regulatory Affairs About the Company Well-funded biotechnology (BioTech) company Industry Biotechnology Type Privately Held 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 over 10 years' of regulatory experience in the biotechnology or pharmaceutical industry, 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 minimum of 10 years' of regulatory experience in the biotechnology or pharmaceutical sector, with a strong preference for those with a background in ophthalmology, especially in 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 successful candidate will be a strategic thinker, capable of shaping global development strategy, and must be comfortable with a hands-on approach as the first regulatory hire. Key qualifications include a proven track record in leading regulatory aspects of clinical development, and the ability to manage and influence in a high-growth, clinical-stage biotech setting. Hiring Manager Title Chief Medical Officer Travel Percent Less than 10% Functions Business Development