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.