Rutgers, the State University of New Jersey is seeking a Regulatory Affairs Manager for the Office of Human Research Services at Rutgers Cancer Institute of New Jersey.
The primary purpose of the Manager, Regulatory Affairs serves as the communications lead for regulatory affairs to support all Scientific Review, Biosafety Review, and FDA submission activities at the Rutgers Cancer Institute of New Jersey. This individual is responsible for planning, directing and monitoring the daily work of all staff supporting the Scientific Review Board. The scope of work includes management of all Protocol Review and Monitoring System activities, monitoring compliance with Clinicaltrials.gov requirements, submission and maintenance of all Investigational New Drug (IND) applications, and submission of Institutional Biosafety Committee (IBC) application. Assures that all clinical research conducted within the Cancer Institute is according to Good Clinical Practice (GCP) guidelines as well as applicable Institutional, State and Federal regulations and guidelines. Assists the Research Study Manager, Regulatory Affairs in ensuring adherence to protocols, regulations, and deadlines.
Among the key duties of this position are the following:
Responsible for the supervision of day-to-day clinical research operations as they relate to Protocol Review and Monitoring System (PRMS) activities.
Manages and actively supports the Investigational New Drug filings(including New INDs, amendments, exemptions, deviations, an annual and safety reports), and all related regulatory filings.
In collaboration with the Manager, Quality Assurance supports the planning, preparation and execution of all monitoring and auditing activities related to INDs and/or clinical trials under their auspice.
Works with regulatory affairs staff to submit and track all submissions to the Institutional Biosafety Committee.
Manages the processes surrounding registration of all Cancer Institute applicable clinical trials(
Internal Number: 122582
About Rutgers University
Rutgers, The State University of New Jersey, is a leading national public research university and the state's preeminent, comprehensive public institution of higher education. Rutgers is dedicated to teaching that meets the highest standards of excellence; to conducting research that breaks new ground; and to turning knowledge into solutions for local, national, and global communities. As it was at our founding in 1766, the heart of our mission is preparing students to become productive members of society and good citizens of the world. Rutgers teaches across the full educational spectrum: preschool to precollege; undergraduate to graduate and postdoctoral; and continuing education for professional and personal advancement. Rutgers is New Jersey's land-grant institution and one of the nation's foremost research universities, and as such, we educate, make discoveries, serve as an engine of economic growth, and generate ideas for improving people's lives.