Senior Director, Clinical Regulatory Affairs
Umoja Biopharma(12 days ago)
About this role
Umoja Biopharma is a biotech company developing integrated immunotherapies to treat cancer, with sites in Seattle, WA and Louisville, CO. The Senior/Executive Director, Regulatory Affairs will lead regulatory strategy and oversee submission content for in vivo CAR‑T therapy programs to support IND, BLA/NDA and global registrations. The role partners with cross‑functional teams and health authorities to advance programs through development and approval.
Required Skills
- Regulatory Strategy
- Regulatory Filings
- IND Filings
- BLA/CTA
- Cell Therapy
- Gene Therapy
- CAR-T
- Clinical Development
- CMC
- Cross-Functional Collaboration
+2 more
Qualifications
- PhD
- MS
- BS
About Umoja Biopharma
umoja-biopharma.comUmoja Biopharma is a biotechnology company developing engineered cellular immunotherapies to treat cancer. The company focuses on next‑generation, off‑the‑shelf immune cell products that use proprietary engineering to improve tumor targeting, persistence and safety. Umoja advances its programs through preclinical and clinical development while building scalable manufacturing and industry and academic partnerships to broaden patient access.
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