Senior Director, Regulatory Affairs

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 Affairs.

• Serve as the global regulatory lead on assigned programs, providing strategic guidance to cross-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations, Medical Affairs, and Commercial).

• Lead the planning, preparation, and submission of high-quality regulatory documents to FDA, including INDs, briefing documents, orphan/breakthrough designations, amendments, annual reports, and NDA/BLAs. Collaborate with external vendors for submissions in other regions.

• Plan, prepare, and lead health authority interactions, including pre-IND, Type B/C, EOP, and pre-submission meetings; coach and prepare cross-functional teams for successful engagements.

• Lead and manage a small US team of regulatory professionals; set priorities, allocate work, and cultivate a collaborative, accountable team culture.

• Anticipate regulatory risks across regions and proactively design mitigation strategies; advise on regulatory implications of program decisions.

• Monitor and interpret evolving global regulations, ICH guidelines, and oncology-specific policies (e.g., Project Optimus, accelerated approval reform), and translate them into actionable strategy.

• Partner with external collaborators, CROs, regulatory consultants, and co-development partners to ensure aligned, efficient execution of global regulatory plans.

• Ensure compliance with applicable global regulations and internal quality and SOP requirements; maintain audit-ready regulatory documentation and inspection readiness.

Qualifications

• Bachelor's degree in a life sciences discipline required; advanced degree (MS, PharmD, PhD, or MD) preferred.

• 10-12 years of progressive regulatory affairs experience in the biotech or pharmaceutical industry.

• Prior oncology/hematology regulatory experience required, with a track record of contributing to oncology development programs across multiple phases.

• Demonstrated experience leading global regulatory strategy, including direct engagement with FDA and EMA; experience with additional ICH regions (e.g., PMDA, Health Canada) strongly preferred.

• Proven success leading and preparing teams for health authority meetings and delivering major regulatory submissions (IND/CTA and, ideally, NDA/BLA/MAA).

• Demonstrated ability to manage within a cross-functional matrix; prior people management experience highly preferred.

• Deep working knowledge of global regulatory requirements, ICH guidelines, and oncology-specific frameworks and expedited pathways (e.g., Breakthrough Therapy, Fast Track, Accelerated Approval, PRIME, orphan drug).

• Strong leadership, influencing, and project management skills; comfortable operating within a nimble and fast-paced environment typical of a small, clinical-stage biotech.

• Exceptional written and verbal communication skills, including experience presenting to and negotiating with health authorities and senior internal stakeholders.

• Detail-oriented, highly organized, and able to manage multiple priorities and competing deadlines.

Company Overview

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.