Executive with over thirty years experience in drug development in various theraputic areas. Extensive experience in regulatory, project and program management, clinical operations, international clinical trials, compliance and overall drug development.Very experienced in filing INDs, NDAs, CTAs, MAAs, Orphan Drug Applications, Pediatric Submissions, and interacting with many different regulatory authorities. Experienced in United States, Canada, European Union, India and South America in both regulatory affairs and clinical trials. Excellent communicator with extensive list of presentations for numerous professional organizations. I have a proven track-record of working with multi-level teams, managing people, overseeing and facilitating pharmaceutical development for Regulatory and Clinical functions for both investigational and approved drugs.I have led many international project teams and am used to working in a matrixed environment. Specialties: Regulatory strategy world wide, clinical operations, international clinical trials, strategic drug development plans, project management, compliance, auditing.