Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning. Partner with the Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings , to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for highly complex programs.