Regulatory Affairs & Business Operations
Regulatory Affairs and Business Operations at NYU Langone consists of two main units that provide support for research.
Our Regulatory Affairs unit guides the development and coordination of FDA submissions, including Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications for studies evaluating drugs and devices that are not FDA approved. We also assist researchers with registration, annual record verification, and results reporting on clinicaltrials.gov in compliance with U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), and International Committee of Medical Journal Editors (ICMJE) requirements. Additionally, our unit manages the iConnect suite of clinical research utilities, which help to connect researchers and potential participants.
The Business Operations unit oversees the implementation of strategic initiatives, process improvement, and program management to support the successful administration of clinical and sponsored research.
David Wallach, MPH, CIP
Director, Regulatory Affairs and Business Operations
Jayne Kim, PhD
Assistant Director, Regulatory Affairs
Gianella Di Lorenzo
Joaquín Effertz, MPH
Program Manager, Business Operations
Specialist, Regulatory Affairs