Manager I, Global Submission Management - CMC

The Manager, Global Submission Management - CMC supports end-to-end regulatory activities for assigned projects, leading the preparation, compilation, and delivery of compliant US IND, CTA, and marketing application submissions for global health authorities. This role partners closely with cross-functional teams to ensure timely development and submission of CMC regulatory content throughout the product lifecycle while supporting continuous improvement initiatives. The position requires strong project management skills and proficiency in regulatory systems to drive submission strategies and maintain compliance with global standards.