AMAG Pharmaceuticals announced that Helen Milton has been appointed as AMAG’s Regulatory Affairs vice president. She will be responsible for regulatory activities along with company’s upcoming regulatory filings, which include a supplemental new drug application submission in mid-2017 as well as the submission of a new drug application in early 2018 for bremelanotide.
Dr. Milton has significant experience filing a broad array of regulatory submissions, and has led drug safety and risk management activities both from a US and global perspective. Prior to joining AMAG, she served in leadership roles at Keryx Biopharmaceuticals, Sunovion Pharmaceuticals and Pfizer. Dr. Milton received her doctorate in pharmacology from the University of Liverpool.
AMAG chief medical officer and senior VP of clinical development and regulatory affairs, Julie Krop said that they are delighted to have Helen join the AMAG team. She has more than two decades of senior-level experience in clinical drug development and global regulatory affairs and has supported the advancement of products across a broad array of therapeutic areas, including renal, central nervous system, respiratory and oncology. Helen’s deep knowledge of the regulatory and pharmaceutical landscape will be extremely valuable to AMAG as they continue to make progress with their product and lifecycle development strategies.