Location:

Watertown, MA - Hybrid, 2-3 days/week onsite Reports to: Chief Medical Officer Position Summary This individual will lead regulatory strategy and execution for growing clinical-stage oncology pipeline. The role will work closely with Clinical Development, Clinical Operations, CMC, Quality, and external regulatory partners to advance programs through Phase 1 and Phase 2 development in the U.S., EU, and UK. This is a hands-on role for someone who can think strategically, work independently, and help build Regulatory Affairs capabilities as the clinical pipeline grows. Key Responsibilities Develop and execute regulatory strategy for Phase 1 and Phase 2 oncology programs. Lead INDs, CTAs, amendments, and other regulatory submissions. Lead and coordinate interactions with FDA and international health authorities. Support clinical development across the U.S., EU/CTIS, and UK/MHRA. Partner with Clinical, CMC, and Quality teams on regulatory strategy and development decisions. Provide regulatory guidance on protocols, development plans, CMC changes, and clinical trial expansion. Manage external regulatory consultants and vendors as needed. Establish practical regulatory processes and infrastructure appropriate for a growing biotech. Help build the Regulatory Affairs function as additional programs enter clinical development. Qualifications Significant Regulatory Affairs experience within biotechnology or pharmaceutical drug development. Strong experience supporting Phase 1 and Phase 2 oncology programs . Demonstrated experience with U.S. INDs and FDA interactions . Strong experience with EU CTAs/CTIS required. UK/MHRA regulatory experience strongly preferred. Experience developing and executing regulatory strategy, not solely regulatory operations. Working knowledge of CMC regulatory considerations during early clinical development. Small or mid-sized biotech experience strongly preferred. Ability and willingness to remain hands-on while operating as the internal regulatory lead.