Senior Manager, Clinical Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Clinical Regulatory Affairs based in the United States.

This role supports clinical regulatory strategy and execution for innovative in vivo CAR T and cell and gene therapy programs.
You will contribute to global regulatory submissions and health authority interactions across the U.S., Europe, and other international markets.
The position offers the opportunity to work on novel therapies designed to address serious diseases and complex unmet patient needs.
You will collaborate closely with clinical development, operations, medical writing, CMC, pharmacovigilance, nonclinical, and program management teams.
The role combines hands-on regulatory execution with strategic input across early- and mid-stage clinical development programs.
You will help anticipate regulatory risks, navigate evolving requirements, and support high-quality interactions with global health authorities.
This is an opportunity to make a meaningful contribution within a growing, science-driven biotechnology environment.