Ms. Burtis has over 25 years of regulatory and senior management experience. Over the past several years, she has developed and implemented regulatory strategy at two cancer biotechnology companies, resulting in filings for multiple Phase 3 trials. From 2000 to 2003, Ms. Burtis was an Associate Director for World Wide Regulatory Affairs at Wyeth BioPharma. From 1996-2000, she was a Senior Manager of Regulatory Affairs at Genentech. Notably, Ms. Burtis was an FDA Consumer Safety Officer in the Office of Compliance, at the Center for Biologics Evaluation and Research, from 1992-1996. Previously, she spent 12 years as a regulatory, project and operations manager at various medical institutions, including Children’s Hospital, Brigham & Women’s and the American Red Cross. Ms. Burtis has a B.S. degree in Biology from Framingham State College and an MBA in Operations and Strategy from Simmons College. |