Senior Director, Regulatory Affairs

Benefits

Parental leave

Not verified

Non-birth-parent leave

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Family-building benefits

• Fertility benefits: Not verified
• Adoption assistance: Not verified
• Surrogacy assistance: Not verified

Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

Not verified checked Jun 13, 2026

Salary

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401(k) match

Reported from DOL Form 5500 industry filing (not employer-specific)

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Market context

U.S. role benchmark (BLS OEWS)

$61,842 U.S. median for this role

Projected growth (BLS Employment Projections)

+1.9% - Slower

Matched to SOC 11-1021 - Operations aggregate by role bucket.

Source: U.S. Bureau of Labor Statistics, OEWS, May 2024 and Employment Projections, 2024-2034.

Role

Role function

Operations From the posting source checked Jun 20, 2026

Seniority

Senior From the posting source checked Jun 20, 2026

Schedule

Shift type

Not verified

Weekend work

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Company

Company stage

Public-company From the posting source checked Jun 20, 2026

Equity

Offered Verified - SEC 10-K source checked Jun 20, 2026

Application

Cover letter

Not verified

Assessment

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Deadline

Not stated

Where they hire

State eligibility is not yet verified.

About this role

Senior Director, Regulatory Affairs Boston, MA, United States 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.

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