Senior Director, Regulatory Affairs – CAR-T & Cell Therapy

Umoja Biopharma; Seattle (WA); On-site; USD 250,000 - 309,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k match

Paid time off

Commuter benefits

Phone stipend

Job summary

Umoja Biopharma, headquartered in Seattle, WA, seeks a Senior Director/Executive Director of Regulatory Affairs to lead content development and regulatory strategy for CAR‑T programs. This role interfaces with translational medicine, preclinical, clinical, and CMC teams to drive regulatory submissions and interactions with global authorities.

The candidate will oversee IND/CTA/BLA/MAA filings, craft regulatory strategy for first‑in‑class therapies, and mentor teams while traveling ~20% for

Qualifications

• Experience leading regulatory submissions and approvals.
• Strong knowledge of global regulatory requirements for gene and cell therapies.
• Excellent communication and leadership skills.

Responsibilities

• Provide regulatory leadership for in vivo CAR‑T programs.
• Develop and execute global regulatory strategies for indication selection and trial design.
• Lead global regulatory filings (IND/CTA/BLA/MAA) and liaise with health authorities.

Skills

Regulatory leadership

Global regulatory requirements

Cross-functional collaboration

Communication

CAR‑T expertise

Leadership

Education

PhD in scientific field

MS in scientific field

BS in scientific field

Job description

Umoja Biopharma, headquartered in Seattle, WA, seeks a Senior Director/Executive Director of Regulatory Affairs to lead content development and regulatory strategy for CAR‑T programs. This role interfaces with translational medicine, preclinical, clinical, and CMC teams to drive regulatory submissions and interactions with global authorities.

The candidate will oversee IND/CTA/BLA/MAA filings, craft regulatory strategy for first‑in‑class therapies, and mentor teams while traveling ~20% for