Vice President of Regulatory Affairs Greater Boston, MA Area

The Company is in search of a Senior Director or VP of Regulatory Affairs to join their dynamic Clinical Development team. The successful candidate will be a key leader in the development and execution of the company's regulatory strategy, with a focus on ensuring alignment with corporate objectives, clinical and commercial milestones, and applicable regulations. This role requires a proven track record in leading successful BLA submissions, particularly for oncology products, and the ability to serve as a senior regulatory subject matter expert and strategic advisor to the Executive Leadership Team. The VP will be responsible for building and scaling the regulatory function, developing proactive regulatory strategies, and providing leadership for all regulatory activities, including IND and BLA filings, and interactions with global health authorities. Applicants must have an advanced degree in a life/health sciences or healthcare-related field, with at least 12 years of relevant industry experience, or a Bachelor's degree with 15+ years of experience. A minimum of 5 years in a leadership role within regulatory affairs, preferably in a biotechnology or pharmaceutical company, is required. The ideal candidate will have a deep understanding of the US regulatory landscape, particularly as it pertains to oncology drug development, and experience in developing global regulatory strategies. Strong leadership, communication, and problem-solving skills are essential, as is the ability to manage multiple complex programs and priorities. The role demands a strategic thinker with the ability to influence and collaborate in a fast-paced, diverse, and results-oriented environment.

Hiring Company

Compass Therapeutics Inc.