Director, CMC Regulatory
Umoja Biopharma(12 days ago)
About this role
The Director, CMC Regulatory Affairs at Umoja Biopharma is a senior regulatory leader focused on CMC strategy and regulatory submissions for cell and gene therapy programs, including in vivo CAR-T. The role partners with global regulatory, development, and technical teams to support product development and eventual licensure.
Required Skills
- CMC
- Regulatory Strategy
- Regulatory Filings
- IND
- NDA
- DMF
- CTD
- Agency Interaction
- Project Management
- Cross-Functional Collaboration
+6 more
Qualifications
- PhD in Relevant Scientific Field
- MS in Relevant Scientific Field
- BA in Relevant Scientific Field
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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