Elizabeth Oestreich

Vice President, Regulatory Compliance

Background

  • Legal, Public Policy, and Non-Profit Sector

Specialty

  • Regulatory Compliance
  • The Family Smoking Prevention and Tobacco Control Act and FDA regulation of Tobacco products
  • FDA Regulation of Cannabidiol (CBD)

Experience

  • 8+ years of FDA regulatory experience. Previously served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, DC

Elizabeth brings more than eight years of regulatory experience and a diverse background of legal, public policy, and non-profit sector knowledge to her position as Vice President of Regulatory Compliance.

As a consultant, Elizabeth provides strategic guidance on premarket and postmarket issues, specifically related to regulatory compliance.  She works with pharmaceutical and medical device clients to prepare for FDA inspection and remediate compliance matters through 483 and warning letter responses. She offers guidance on quality system management and how to build a culture of quality. Elizabeth also advises clients navigating the regulatory landscape for tobacco products and assists with content and format of applications, interpretation of FDA regulation, communication with the FDA, and analysis of proposed rules. 

Additionally, Elizabeth is well versed in the regulatory barriers facing the rapidly growing CBD industry. She offers strategic guidance and risk-based strategies to CBD manufacturers and distributors as the FDA contemplates how to regulate the product category.

Prior to joining Greenleaf Health, Elizabeth served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, DC. While at FDLI, she gained extensive experience in all FDA-regulated product areas. Elizabeth’s role included regularly corresponding with FDA officials, as well as creating and supervising the development of curricula for an array of educational programs. Elizabeth led FDLI’s committees responsible for monitoring regulatory developments in the tobacco and pharmaceutical industries and served as Editor-in-Chief of the Food and Drug Law Journal. 

Before earning her law degree, Elizabeth worked as a government relations professional for the Society of Chemical Manufacturers and Affiliates (SOCMA), where she directed a grassroots network of more than 100 member companies. Elizabeth earned a B.S. in Political Science from the University of Arizona and a J.D. from the University of the District of Columbia’s David A. Clarke School of Law.