Bob Iser is currently a Vice President with PAREXEL Consulting where he provides technical leadership and expertise including development of global regulatory strategies on behalf of PAREXEL clients interfacing with Regulatory Agencies and through leading a team of global regulatory experts. Prior to joining PAREXEL, Bob spent 14 years with the U.S. FDA (most recently as the Director of the Office of Process and Facilities in CDER) with experience in CMC review, pre-approval inspections, CGMPs, guidance & policy development, and training. Before joining the FDA, he worked for seven years in the biopharmaceutical industry as a quality professional with both QC and QA functional experience; and support of product and process development, analytical method and process validation, as well as, commercial operations. Bob has co-authored a number of articles including several CMC common deficiency articles, has served on both ICH and USP expert working groups, and is a routine speaker on CMC, CGMP and policy topics at both domestic and international conferences. Bob earned a M.S. in Chemistry from Wright State University (Dayton, Ohio) and a B.S. in Chemistry from Muskingum University.