Senior Director, Regulatory Affairs
Bicara Therapeutics
August 12, 2026
Remote friendly (Boston, MA)
United States
$275,000 - $315,000 USD yearly
Corporate Functions
Responsibilities:
- Develop and execute integrated global regulatory strategies for investigational oncology assets through approval and lifecycle management.
- Serve as global regulatory lead for assigned programs, providing strategic guidance to cross-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations, Medical Affairs, Commercial).
- Lead planning, preparation, and submission of high-quality regulatory documents to FDA (INDs, briefing documents, orphan/breakthrough designations, amendments, annual reports, NDA/BLAs); coordinate with external vendors for other regions.
- Plan, prepare, and lead health authority interactions (pre-IND, Type B/C, EOP, pre-submission meetings); coach cross-functional teams for successful engagements.
- Lead and manage a small US regulatory team; set priorities, allocate work, and cultivate a collaborative, accountable culture.
- Anticipate regulatory risks across regions and design mitigation strategies; advise on regulatory implications of program decisions.
- Monitor and interpret evolving global regulations, ICH guidelines, and oncology-specific policies; translate into actionable strategy.
- Partner with external collaborators, CROs, regulatory consultants, and co-development partners to align and execute global regulatory plans.
- Ensure compliance with global regulations and internal quality/SOPs; maintain audit-ready documentation and inspection readiness.
Qualifications:
- Bachelor’s degree in a life sciences discipline required; advanced degree (MS, PharmD, PhD, MD) preferred.
- 10–12 years progressive regulatory affairs experience in biotech/pharma.
- Prior oncology/hematology regulatory experience across multiple development phases.
- Experience leading global regulatory strategy with direct FDA/EMA engagement; additional ICH regions (e.g., PMDA, Health Canada) strongly preferred.
- Successful health authority meeting leadership and major submissions (IND/CTA and ideally NDA/BLA/MAA).
- Ability to manage in a cross-functional matrix; people management highly preferred.
- Deep knowledge of global regulatory requirements, ICH guidelines, oncology expedited pathways (Breakthrough Therapy, Fast Track, Accelerated Approval, PRIME, orphan drug).
- Strong leadership, influencing, and project management; comfortable in a fast-paced small biotech.
- Exceptional written/verbal communication; experience presenting and negotiating with health authorities and senior stakeholders.
- Detail-oriented, highly organized; able to manage multiple priorities and competing deadlines.
Compensation Range:
- $275K–$315K
- Develop and execute integrated global regulatory strategies for investigational oncology assets through approval and lifecycle management.
- Serve as global regulatory lead for assigned programs, providing strategic guidance to cross-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations, Medical Affairs, Commercial).
- Lead planning, preparation, and submission of high-quality regulatory documents to FDA (INDs, briefing documents, orphan/breakthrough designations, amendments, annual reports, NDA/BLAs); coordinate with external vendors for other regions.
- Plan, prepare, and lead health authority interactions (pre-IND, Type B/C, EOP, pre-submission meetings); coach cross-functional teams for successful engagements.
- Lead and manage a small US regulatory team; set priorities, allocate work, and cultivate a collaborative, accountable culture.
- Anticipate regulatory risks across regions and design mitigation strategies; advise on regulatory implications of program decisions.
- Monitor and interpret evolving global regulations, ICH guidelines, and oncology-specific policies; translate into actionable strategy.
- Partner with external collaborators, CROs, regulatory consultants, and co-development partners to align and execute global regulatory plans.
- Ensure compliance with global regulations and internal quality/SOPs; maintain audit-ready documentation and inspection readiness.
Qualifications:
- Bachelor’s degree in a life sciences discipline required; advanced degree (MS, PharmD, PhD, MD) preferred.
- 10–12 years progressive regulatory affairs experience in biotech/pharma.
- Prior oncology/hematology regulatory experience across multiple development phases.
- Experience leading global regulatory strategy with direct FDA/EMA engagement; additional ICH regions (e.g., PMDA, Health Canada) strongly preferred.
- Successful health authority meeting leadership and major submissions (IND/CTA and ideally NDA/BLA/MAA).
- Ability to manage in a cross-functional matrix; people management highly preferred.
- Deep knowledge of global regulatory requirements, ICH guidelines, oncology expedited pathways (Breakthrough Therapy, Fast Track, Accelerated Approval, PRIME, orphan drug).
- Strong leadership, influencing, and project management; comfortable in a fast-paced small biotech.
- Exceptional written/verbal communication; experience presenting and negotiating with health authorities and senior stakeholders.
- Detail-oriented, highly organized; able to manage multiple priorities and competing deadlines.
Compensation Range:
- $275K–$315K