Coordinate and lead meetings with regulatory agencies including preparation and development of meeting strategies, briefing book roundtables and packages, cross-functional preparation, regulatory notifications, regulatory document workflows, agency interactions, responses to agency questions, and follow-up commitments. Orchestrate and deliver successful IND and BLA filings, amendments, supplements, reports, meeting requests, briefing packages, and any regulatory submissions, ensuring high-quality, timely, consistent and coordinated submissions, that meet technical and regulatory requirements.