25+ years clinical research experience in roles of increasing responsibility with a recent career change from Project Management to Global Regulatory Affairs. Background in clinical operations and project management has been a strong asset as a regulatory affairs leader.5+ years in regulatory affairs; certified Regulatory Affairs Professional (RAC, drugs); 15+ years in project management; certified Project Management Professional (PMP)®Selected to serve as the Clinical Lead for the submission of an NDA to the US FDA for a novel new molecular entity (COSELA™); planned, managed and tracked all documents contributing to Module 5 of the NDA submission; collaborated with the clinical development team to plan, manage, track, author, review and publish four clinical study reports, associated appendices and over 300 clinical narratives; managed resources across functions to ensure activities could be done in parallel to ensure NDA target submission date was met; trained and managed team of independent quality control reviewers to ensure all clinical documents contributing to Module 5 of the NDA submission were complete and accurate in the eCTD; insured inspection readiness for clinical operations; this role was the impetus for a formal career change to regulatory affairs.Responsible for planning, preparing and co-authoring key regulatory documents including INDs for new indications, agreed initial Pediatric Study Plans, Fast Track Designation Requests, meeting requests and briefing packages, IMPDs; compiles and prepares documentation for global clinical trial applications (EU, UK, Turkey, Ukraine, Russia, Georgia, Moldova).Clinical Regulatory Lead for a matrix/cross-functional team; collaborates with teams to develop and ensure execution of regulatory strategy that aligns with company goals; provides guidance to teams to reduce regulatory risk; reviews clinical protocols to ensure regulatory requirements are met and to ensure studies are aligned with current agency thinking and standard of care; worked with department to develop a set of activities that are standard for the clinical regulatory lead role to build efficiencies and ensure consistency.Serve as company liaison for US and ex-US regulatory agencies; prepare and respond to inquiries; maintain the US IND to include amendment submissions as needed.Comfortable synthesizing and communicating nuance of regulatory guidance to study teams.Long history with oncology products; current therapeutic area experience in breast cancer. Past experience in other solid tumors and HIV.