Bonnie is an experienced regulatory affairs professional whose expertise includes CMC regulatory affairs support, as well as general regulatory affairs support, during the pre- and post-marketing phases of development. Specifically, Bonnie has managed the planning and preparation of numerous regulatory submissions including NDAs, NDA amendments/supplements, MAAs, NDSs, INDs and IND amendments, IND and NDA Annual Reports, IMPDs, and CTAs. Bonnie has developed regulatory strategies for pharmaceutical and biopharmaceutical companies seeking investigational and marketing approvals in the U.S., Europe and Canada. She has coordinated and participated in teleconferences and face-to-face meetings with FDA and Health Canada. Bonnie has a B.S. in General Biology and a B.S. in Marine Biology from the University of Massachusetts at Dartmouth.