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

Job Title: Client Dedicated CMC Regulatory Manager/Senior Manager - US & Canada Job Location: Remote, North Carolina, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description This is a position to lead and execute global CMC regulatory strategy and submissions, ensuring the delivery of high-quality CMC dossiers in full compliance with US & CA regulatory requirements. CMC Regulatory Strategy and submissions for Biologicals : Lead the development and execution of CMC regulatory strategies for biological products Serve as the subject matter expert on biologics, providing CMC regulatory guidance for the preparation of regulatory submissions to the regional agencies (FDA, Health Canada). Act as the primary liaison for CMC regulatory matters related to biologicals, collaborating with global teams (R&D, Quality, Manufacturing, Global Regulatory) to align on submission strategies. Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAAs and variations. Author, compile, and maintain CTD Module 3 content as applicable. Coordinate responses to CMC-related questions and deficiencies raised by the Health Authorities Post-Approval Compliance and Lifecycle Management : Perform regulatory impact assessments for CMC change controls and quality events, with a focus on U.S. FDA and Health Canada regulatory requirements and reporting classifications Lead the preparation, authoring, review, and coordination of Annual Reports for U.S. and Canadian marketing applications, ensuring accurate reporting of post-approval CMC changes and Commitments. Lead the preparation, authoring, review, and coordination of Yearly Biologic Product Report (YBPR) for Canadian marketing, ensuring accurate reporting of post-approval Quality changes. Author, review, and compile Module 1 documentations for commercial submission