Reporting to the Vice President, Project Management, this role will be highly hands-on, owning the planning, coordination, and execution of regulatory CMC submissions — including BLAs and Prior Approval Supplements — while partnering closely with CMC subject matter experts and external manufacturing partners. Essential Functions: Project Management for the planning, coordination, and execution of regulatory CMC submissions, including Biologics License Applications (BLA), Prior Approval Supplements (PAS), and other regulatory filings, ensuring cross-functional CMC content is authored, reviewed, and delivered on schedule.