Clinical Regulatory Lead for Cell & Gene Therapies

Umoja Biopharma seeks a Senior Manager or Associate Director of Regulatory Affairs to drive clinical regulatory strategy and submissions for in vivo CAR-T and cell/gene therapy programs. This role involves global health authority interactions across the US, EU, and beyond, with collaboration across clinical, medical writing, pharmacovigilance, and CMC teams.

The candidate will plan FDA/EMA meetings, develop briefing materials, and ensure timely regulatory deliverables, while maintaining