Senior Director, Regulatory Affairs

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.

Strong understanding of FDA, EMA, and international guidelines.

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.

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.