Client Dedicated CMC Regulatory Manager/Senior Manager - US & Canada
Lifelancer · Other
Source: Himalayas
This role’s source listing does not include Hungary as an eligible location.
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.
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About the Company
Lifelancer is a talent-hiring platform specialized in connecting professionals with career opportunities in the life sciences, pharmaceutical, and IT sectors. It facilitates recruitment for roles within organizations that focus on health sciences, biotech, and healthtech.