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

About this job

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.…

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