Bicara Therapeutics
Senior Director, Regulatory Affairs
Boston · Director
Sponsorship not specifiedDetected 71 days ago
Project ManagementFDA RegulatoryLeadershipCommunicationMentoringPublic SpeakingOrganizational SkillsBiostatisticsRegulatory Affairs
About the role
- This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.
- Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation.
- For more information, please visit www.bicara.com http://www.bicara.com.
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.
- Lead and manage a small US team of regulatory professionals
- Anticipate regulatory risks across regions and proactively design mitigation strategies
- Partner with external collaborators, CROs, regulatory consultants, and co-development partners to ensure aligned, efficient execution of global regulatory plans.
- maintain audit-ready regulatory documentation and inspection readiness.
Requirements
- 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.
- 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).
- 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
- 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.
Nice to have
- Bachelor's degree in a life sciences discipline required
- advanced degree (MS, PharmD, PhD, or MD) preferred.
- Demonstrated experience leading global regulatory strategy, including direct engagement with FDA and EMA
- prior people management experience highly preferred.
Compensation
- 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.
Benefits
- 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).
- Plan, prepare, and lead health authority interactions, including pre-IND, Type B/C, EOP, and pre-submission meetings
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