Peggy J. Berry, MBA, RAC, is the Principal Consultant at Synergy where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs, and project management topics.
Prior to founding Synergy Consulting, she was Vice President of Regulatory Affairs at Insmed, where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Before she joined Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin. She also held a variety of senior level positions at Dyax, MGI Pharma (now Eisai), AstraZeneca, and Dey Pharma (now Mylan). She has held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd) and has worked in review divisions at the FDA. She also consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.
Peggy is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).