Client Dedicated CMC Regulatory Manager/Senior Manager - US & Canada
Core
Lead global CMC regulatory strategy and submissions for biological products, ensuring compliance with US and Canadian regulatory requirements.
Role type
Senior Manager, CMC Regulatory (Biologics)
Builds
CMC dossiers (Module 3), regulatory filings (MAAs, variations), Annual Reports, YBPR, and Module 1 documentation for US and Canada.
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
CMC regulatory strategy, biologics manufacturing knowledge, regulatory submissions (FDA/Health Canada), lifecycle management, project management
Preferred skills
EMA regulations, ICH guidelines, cross-functional team leadership
Technologies
CTD Module 3, FDA Forms, Reviewer's guide, Note to Reviewer
Responsibilities
Lead CMC regulatory strategies for biological products; oversee preparation and submission of CMC sections in regulatory filings; perform regulatory impact assessments for CMC change controls; lead preparation of Annual Reports and Yearly Biologic Product Reports; manage post-approval changes including manufacturing process changes and site transfers; monitor and assess regulatory guidance related to biologics.
Seniority
Senior Manager, strategic execution & cross-functional leadership