Position Overview

Bicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the VP, Regulatory Affairs, you will serve as the primary US regulatory lead with a core focus on BLA strategy and execution—from IND through BLA submission and approval. You will manage a small team of Regulatory Affairs professionals, providing mentorship and oversight while working in close partnership with the VP to ensure alignment on regulatory direction, agency interactions, and submission timelines.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

• Develop and execute integrated global regulatory strategies to advance investigational oncology assets from early development through approval and lifecycle management, partnering closely with the VP, Regulatory Affai...