Job Title: Senior CMC Regulatory Affairs Scientist
Job Description
The Senior CMC Regulatory Affairs Scientist leads the design and evaluation of chemistry, manufacturing, and controls (CMC) studies to meet regulatory requirements and defines robust regulatory strategies for United States submissions. This role prepares and oversees CMC submissions to ensure they meet regulatory expectations and support product portfolio growth and lifecycle management. The position serves as a technical-regulatory expert, partnering closely with R&D, pharmaceutical development, industrial operations, and external partners to optimize regulatory strategies, streamline data use globally, and support both pre- and post-approval activities.
Responsibilities

+ Lead or oversee the development of US CMC technical-regulatory strategies for assigned projects as part of US or international R&D teams or in direct collaboration with contract organizations.

+ Prepare comprehensive techni...