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 U.S. Food and Drug Administration (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 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.

Contact Us

David Wallach, MPH, CIP
Director, Regulatory Affairs and Business Operations
646-754-4624
David.Wallach@NYULangone.org

Jayne Kim, PhD
Assistant Director, Regulatory Affairs
646-754-7026
Jayne.Kim@NYULangone.org

Stephanie Montenegro, MS
Program Manager, Business Operations
646-754-4520
Stephanie.Montenegro@NYULangone.org

Joaquín Effertz, MPH
Program Coordinator, Regulatory Affairs & Business Operations
646-754-4986
Joaquin.Effertz@NYULangone.org

Mark Bond
Specialist, Regulatory Affairs
646-754-7217
Mark.Bond@NYULangone.org

Jennifer Coffey, MS
Specialist, Regulatory Affairs
212-404-4219
Jennifer.Coffey@NYULangone.org