Manoj Amaraneni brings years of experience in pharmaceutical regulatory affairs to Galt, serving as the site’s head of regulatory affairs and pharmacovigilance. Manoj is an experienced manager with broad experience and success providing support for regulatory agency interactions in addition to IND, NDA, ANDA, and PAS filings and approvals. He has a strong understanding of regulatory, clinical development, and life cycle management filing requirements, including post approval support for phase IV, pharmacovigilance, and supplemental approvals. At Galt, Manoj will provide strategic and operational leadership in the management of all aspects of clinical development, quality, and regulatory compliance and works closely with FDA to streamline the development of all Galt’s products. He also provides critical insights to discover and develop drugs which will safely provide clinically relevant benefits desired by patients.
Manoj completed his Bachelor’s in Pharmacy from India and received his Master’s in Regulatory Affairs and Doctorate in Toxicology from the University of Georgia. He is a member of RAPS and is RAC (US) certified by the Regulatory Affairs Certification Board.
