The Company is seeking a Vice President, Regulatory Affairs to lead and build the global regulatory function and strategy for its innovative gene editing therapies. The successful candidate will be the primary regulatory expert and strategic advisor, overseeing all regulatory activities from development candidate selection to marketing authorization. This hands-on role requires a leader who can define and execute an integrated global regulatory strategy, lead regulatory interactions with health authorities, and anticipate and address gene editing-specific issues. The VP will also be responsible for maintaining inspection-ready regulatory documentation, representing the company in external forums, and ensuring the regulatory function is fit-for-purpose and compliant with evolving global policies. To thrive in this position, candidates should have an advanced degree in a scientific, medical, pharmacy, engineering, or related discipline, with a preference for a Ph.D. or equivalent. A minimum of 15 years' experience in biotechnology or pharmaceutical regulatory affairs is required, with a proven track record of global regulatory strategy and major submissions for innovative therapeutics. Experience in CRISPR or other gene editing therapeutics is highly valued, as is a background in rare or genetic diseases, orphan-drug development, and advanced therapeutic modalities. The ideal candidate will have exceptional executive communication, scientific judgment, negotiation, and decision-making skills, and be adept at balancing high-level strategy with day-to-day execution in a fast-paced biotech environment.

Hiring Company

Editas Medicine, Inc.