Director, Regulatory Affairs

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.