Client Dedicated CMC Regulatory Manager/Senior Manager - US & Canada

Lifelancer is hiring a CMC Regulatory Manager/Senior Manager to lead biological product regulatory strategy and submissions within the United States. This is a fully remote, full-time role requiring extensive experience in FDA and Health Canada compliance.

The successful candidate will act as the primary liaison for CMC regulatory matters, overseeing the preparation of Module 3 dossiers for biological products. The role involves performing regulatory impact assessments for post-approval changes and leading the development of annual reports and manufacturing process updates. Applicants must demonstrate deep expertise in ICH guidelines and biologics characterization to support global regulatory compliance.