Senior Director, Clinical Regulatory Affairs
About The Position
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. We are seeking an accomplished and strategic Senior Director, Clinical Regulatory Affairs to shape global clinical regulatory strategy across our pipeline, with a particular focus on programs in Type 1 diabetes, oncology, and autoimmune disease. This role is ideal for a seasoned regulatory leader who is excited by science‑driven development, cross‑functional collaboration, and advancing therapies for serious diseases. You will develop and execute comprehensive regulatory strategies for clinical‑stage programs, guide teams on global regulatory requirements, and help shape the long-term regulatory vision for the portfolio from Phase 1 to commercialization. Clinical-stage regulatory experience in our therapeutic areas of focus (Type 1 diabetes, oncology, autoimmune disease) and cell/gene therapies is preferred. Experience in regulatory operations and/or ex-US submission planning are also considered beneficial for the role. This position reports to the Vice President, Head of Regulatory Affairs and would work out of Sana’s offices in Cambridge (preferred), South San Francisco, or Seattle.
Requirements
- Bachelor’s degree required, advanced degree in relevant scientific field preferred.
- 10+ years of regulatory affairs experience in biopharmaceutical industry; experience with cell and/or gene therapy products highly desirable.
- Demonstrated success in preparing and leading IND/CTA submissions, pivotal-stage amendments, BLA/MAAs, and any associated regulatory interactions.
- Clinical-stage regulatory experience in Sana’s therapeutic areas of focus (Type 1 diabetes, oncology, autoimmune disease) and cell/gene therapies preferred.
- Demonstrated ability to lead regulatory strategy through complex decision points and influence cross-functional teams at the senior level.
- Demonstrated ability to collaborate productively across a broad array of functional areas, as well as raise and entertain different points of view and regulatory options.
- Experience in regulatory operations, and/or ex-US submission planning beneficial, though not required.
- Strong understanding of FDA, EMA, and international guidelines.
- Excellent oral and written communication skills.
- Ability to work from Sana offices in Cambridge, MA is preferred; will consider candidates who can work from our offices in South San Francisco, CA or Seattle, WA.
Nice To Haves
- Deep motivation to advance therapies for people with serious unmet needs.
- Intellectual curiosity and scientific rigor.
- Strong skills in matrix leadership, influencing without direct authority
Responsibilities
- Direct clinical regulatory strategies for assigned programs, with emphasis on Type 1 diabetes, oncology, and autoimmune disease assets.
- Create regulatory development plans, including key milestones, registration strategies, health authority engagement plans, expedited pathways, pediatric development, and risk assessments.
- Partner closely with Clinical Development, CMC Regulatory Affairs, Clinical Operations, Safety, Technical Operations, and Program Leadership.
- Lead and/or oversee global regulatory submissions and health authority interactions/meetings.
- Provide strategic input into labeling, target product profiles, and benefit‑risk considerations.
- Serve as a senior regulatory representative on cross‑functional program teams.
- Lead regulatory operations improvement efforts to ensure submission quality, compliance, and efficiency.
- Proactively identify regulatory risks and mitigation strategies.
- Monitor evolving regulatory policy in Sana’s therapeutic areas of focus and for cell/gene therapy modalities.
- Support development of internal regulatory processes.
- Mentor junior regulatory staff.
Benefits
- For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable.
- We offer ample time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
11-50 employees
