Backed by GV.
About the role
Our Clinical Development team is seeking a highly motivated and experienced Senior Director or VP of Regulatory Affairs. The ideal candidate will have a proven track record of leading successful BLA submissions and desires to be part of a results-oriented, fast-paced, and collaborative team. This position reports to our CMO and is onsite 4 days/week in our office in Brighton, MA.
What they're looking for
- Advanced degree in life/health sciences or healthcare related field with 12+ years of relevant life science industry experience, or Bachelor's degree with 15+ years of relevant experience
- Experience operating at the executive level and partnering effectively with senior leadership on complex regulatory and business decisions
- Proven experience leading major regulatory submissions for oncology products, including successful BLA and IND submissions, experience with multiple successful BLA submissions is strongly preferred
- Demonstrated deep understanding of US regulatory landscape, frameworks, and FDA requirements applicable to oncology drug development and commercialization, including compliance and quality guidelines and standards
- Demonstrated expertise developing and executing regulatory strategies across the product lifecycle, from clinical development to approval and, ideally, post-approval activities
- Experience developing global regulatory strategies and engaging with the FDA, EMA, and/or other major health authorities
More about this role
Our Clinical Development team is seeking a highly motivated and experienced Senior Director or VP of Regulatory Affairs. The ideal candidate will have a proven track record of leading successful BLA submissions and desires to be part of a results-oriented, fast-paced, and collaborative team.
This position reports to our CMO and is onsite 4 days/week in our office in Brighton, MA.
- Lead the development and execution of the Company's Regulatory strategy, ensuring alignment with corporate objectives, clinical and commercial milestones, quality standards, and applicable regulations
- Serve as the company's senior Regulatory subject matter expert and strategic advisor to the Executive Leadership Team, providing regulatory perspectives that shape product development, corporate strategy, risk management, commercialization, and successful product approvals
- Build, lead, and scale the Regulatory function, establishing the capabilities, SOPs, systems, and external partnerships required to support the company's transition from clinical development through commercialization
- Develop proactive and coordinated US and ex-US regulatory strategies across the company's pipeline and ensure...
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