Manager, Regulatory CMC (Contract)

The Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Research, to compile and maintain high-quality regulatory submissions. The Manager will assist in the preparation of CMC content for INDs/CTAs and amendments, assess change controls for regulatory impact, and help ensure compliance with applicable US and global regulatory requirements. This position offers an excellent opportunity to grow in regulatory affairs within an innovative, fast-paced biotechnology environment focused on advanced therapies. Responsibilities include regulatory documentation & submissions, change control & compliance support, cross-functional collaboration, and process and documentation support.