Khemraj Hirani

Chief Regulatory Officer at Signos

Khemraj Hirani has over 19 years of experience in the healthcare industry. Khemraj began their career as a Senior Research Fellow in Pharmacology for the Council of Scientific and Industrial Research at Nagpur University in 2002. In 2003, they were a Research Intern for the Neuronal Circuit Mechanisms Research Group at RIKEN. From 2004 to 2006, they worked as a Postdoctoral Research Associate/Biological Scientist at the University of South Florida College of Medicine and as a Registered Pharmacist at Walgreens. In 2008, they began working at the University of Miami Miller School of Medicine, where they held various roles, including Associate Vice Chair for Research and Regulatory Compliance, Deputy Director and Chief Operating Officer (Interim) of the UM Diabetes Research Institute, Director of Regulatory Affairs and Quality Assurance of the Diabetes Research Institute, Co-Director of Regulatory Knowledge and Support for the Clinical and Translational Science Institute CTSA 2.0, Associate Vice Provost for Human Subject Research Office and Institutional Review Boards, and Member of the Data and Safety Monitoring Board for the Sylvester Comprehensive Cancer Center. Khemraj also served as a Clinical Investigator for Phase I to IV, and a Lead Clinical Research Pharmacist for Phase I to IV Investigational Drug Services. In 2020, they became the Chief Regulatory Officer for Signos, and in 2021, they became the Chief Regulatory Officer for Ambulero, Chief Regulatory Advisor/Consultant for Rancho Santa Fe Bio, Inc., SME - Regulatory, Ethics, Clinical Safety and Efficacy During Product Development for GaLaxSar and Associates Consulting LLC, and Scientific Co-Founder and Chief Regulatory Officer for PriZm Tx.

Khemraj Hirani has a diverse educational background. Khemraj completed a Postdoctoral fellowship in Pharmacology, Anatomy and Neuroscience at the University of South Florida from 2004 to 2006. Khemraj then obtained an M.Pharm.-Ph.D. in Pharmacology from Nagpur University from 2001 to 2004. In 2002 to 2003, they completed a Post Graduate Diploma in Business Administration (PGDBM/MBA) at Balaji Institute of Modern Management, focusing on Personnel Management and Business Administration. Khemraj also obtained a Bachelor of Pharmacy (B.Pharm.) from Mangalore University from 1994 to 1998, studying Pharmaceutical Sciences. Additionally, they have obtained several certifications, including a Regulatory Affairs Certification Program (RAC-US) in 2015, a Registered Pharmacist RPH from the State of Florida in 2011, a Certified Clinical Research Professional from SoCRA in 2011, a Certified Healthcare Research Compliance, and a Certified IRB Professional (CIP) from PRIM&R.

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