Senior Director, Clinical Regulatory Affairs

Sana Biotechnology is hiring a Senior Director, Clinical Regulatory Affairs to develop and execute comprehensive regulatory strategies for clinical-stage programs. The ideal candidate has 10+ years of regulatory affairs experience in the biopharmaceutical industry, with a focus on cell and/or gene therapy products. The role requires collaboration with cross-functional teams, leading regulatory strategy, and influencing senior-level decision makers.

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.
• 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.

Benefits

• Paid time off benefits
• Short- and long-term disability
• Employer paid basic life insurance
• Additional voluntary life insurance protection
• Financial wellness programs
• 401(k) Plan with an immediately vested employer match
• Tuition Reimbursement and Student Loan Repayment
• Employee Stock Purchase Plan
• Commuter subsidy
• Wellness offerings