The Regulatory Affairs Specialist (RAS) will be responsible for providing strategic, tactical and operational direction and support to investigators and study teams for working within regulations to expedite the development and delivery of safe and effective healthcare products to DFCI patients and the world. The RAS will work closely and collaboratively with a variety of individuals at all levels throughout DFCI, including faculty, investigators and staff, and also with representatives from the pharmaceutical, biotechnology, and medical device industries, federal and international regulatory agencies, and other research organizations. The RAS will work interactively with the Dana-Farber/Harvard Cancer Center (DF/HCC) Office for Human Research Studies (OHRS) and Office of Data Qual