Senior Director, Regulatory Affairs

Sana Biotechnology

Cambridge, MA, US
Base: $275,000 to $325,000pyear; bonus/equity: not...
On-site
10+ years regulatory affairs experience
Clinical-stage regulatory strategy execution
Ind/cta, bla/maa submission leadership
Sana Biotechnology is seeking a Senior Director of Regulatory Affairs to develop and execute regulatory strategies for clinical-stage programs, particularly in Type 1 diabetes, oncology, and autoimmune diseases. The ideal candidate will have extensive regulatory experience in the biopharmaceutical industry, preferably with cell and gene therapy products, and will work closely with cross-functional teams to advance therapies for serious diseases

Job Summary

  • The role involves developing and executing comprehensive regulatory strategies for clinical-stage programs in Type 1 diabetes, oncology, and autoimmune diseases.
  • Candidates will lead global regulatory submissions, health authority interactions, and provide strategic input into labeling and benefit-risk considerations.
  • Sana Biotechnology offers a competitive base pay range of $275,000 to $325,000 per year along with generous benefits including tuition reimbursement and stock purchase plans.

Matching Summary

Match Score: 85

Sana Biotechnology is seeking a Senior Director of Regulatory Affairs to develop and execute regulatory strategies for clinical-stage programs, particularly in Type 1 diabetes, oncology, and autoimmune diseases. The ideal candidate will have extensive regulatory experience in the biopharmaceutical industry, preferably with cell and gene therapy products, and will work closely with cross-functional teams to advance therapies for serious diseases.

Salary

Base: $275,000 to $325,000/year; Bonus/Equity: Not specified; Benefits: Health coverage, 401(k) match, tuition reimbursement, stock purchase plan

Skills & Requirements

Must-have

  • 10+ years regulatory affairs experience
  • Clinical-stage regulatory strategy execution
  • IND/CTA, BLA/MAA submission leadership

Nice-to-have

  • Cell and gene therapy product experience
  • Type 1 diabetes or oncology therapeutic focus
  • Ex-US submission planning expertise

Key Requirements

  • Bachelor's degree required; advanced degree preferred
  • 10+ years of biopharmaceutical regulatory affairs experience
  • Proven success with pivotal-stage amendments and regulatory interactions

Work Rights

Not specified

Tailored Resume

Cover Letter