Amy Schacterle

Amy leads our regulatory strategy and interactions with health authorities. Under her leadership, our regulatory team fosters innovation and efficiency in developing new treatments for CNS disorders, while ensuring compliance with laws and regulations via transparent and data-driven decision-making. Amy joined us in 2014 and was responsible for building our successful Regulatory and Quality organizations. She continues to progress Sage’s growth with increased focus on global expansion and regulatory policy. Amy came to Sage with extensive expertise in regulatory affairs and development of treatments for CNS disorders, with more than 20 years in the biotech and life science industries. As Vice President, Regulatory Affairs at Sunovion Pharmaceuticals (previously Sepracor), she led the development and commercial regulatory activities for all drug, biologic, and combinations device products at the company’s Marlborough campus. Prior to Sunovion, Amy held leadership roles in regulatory affairs at various biotech and device companies and was an integral part of the quality teams.

Amy received her Ph.D. and M.S. in biomedical engineering at the University of Virginia, and her B.S. in biomedical engineering at Rensselaer Polytechnic Institute. In 2014, Amy was named as one of the Boston Business Journal/Mass High Tech 2014 Women to Watch.