colleen davenport

•Ph.D. in Immunology. Masters in Regulatory Affairs. •10, 3 and 5 years experience in the fields of bone marrow transplantation, autoimmune disorders and cardiovascular diseases, respectively. •8 years experience in regulatory affairs including US and EU regions, multiple therapeutic areas, including new chemical entities and biologics, with development ranging from preclinical to market. •Management experience including supervision of direct reports and local site responsibilities. •Effective communication with FDA, Joint Venture partnerships, academic advisors/key opinion leaders, CROs, and internal project team members/support functions/worldwide affiliates. •Direct experience with preparation of regulatory documents for US and EU submissions, regulatory strategy documents (chronic heart failure and intermittent claudication), and preparation/facilitation of FDA meetings and Advisory Committee Meetings.