Senior Manager Of CMC Regulatory
Actalent • Morristown, NJ • Posted June 16, 2026
About the Role
Senior Manager CMC Regulatory
A Partner to Actalent is seeking an experienced Manager of CMC Regulatory Affairs to lead regulatory strategy and execution across both development and commercial programs. This role is responsible for ensuring that all Chemistry, Manufacturing, and Controls (CMC) regulatory activities are delivered with scientific rigor, operational excellence, and full compliance with FDA expectations. The position requires a seasoned regulatory professional who can navigate complex challenges, drive high‑quality submissions, and collaborate effectively across multidisciplinary teams.
You will work closely with Quality, Technical Operations, Analytical Development, Formulation, and Program Leadership to guide regulatory strategy, shape submission content, and ensure timely delivery of regulatory filings that support product lifecycle success.
Core Responsibilities
+ Regulatory Leadership — Manage all CMC regulatory activities for assigned development an...
A Partner to Actalent is seeking an experienced Manager of CMC Regulatory Affairs to lead regulatory strategy and execution across both development and commercial programs. This role is responsible for ensuring that all Chemistry, Manufacturing, and Controls (CMC) regulatory activities are delivered with scientific rigor, operational excellence, and full compliance with FDA expectations. The position requires a seasoned regulatory professional who can navigate complex challenges, drive high‑quality submissions, and collaborate effectively across multidisciplinary teams.
You will work closely with Quality, Technical Operations, Analytical Development, Formulation, and Program Leadership to guide regulatory strategy, shape submission content, and ensure timely delivery of regulatory filings that support product lifecycle success.
Core Responsibilities
+ Regulatory Leadership — Manage all CMC regulatory activities for assigned development an...