Regulatory Affairs & Business Operations | NYU Langone Health

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Regulatory & Compliance Resources Regulatory Affairs & Business Operations

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 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 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

Jayne Kim, PhD
Assistant Director, Regulatory Affairs

Joaquín Effertz, MPH
Program Manager, Business Operations

Stephanie Montenegro, MS
Program Manager, Business Operations

Mark Bond
Specialist, Regulatory Affairs

Jennifer Coffey, MS
Specialist, Regulatory Affairs