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

  • Served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, DC

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

As a consultant for drug and medical device clients, Elizabeth works to remediate compliance issues ranging from 483 responses, warning letter responses and guidance on how to build a culture of quality within their quality system. In addition, Elizabeth advises clients navigating the regulatory landscape for tobacco products and offers guidance on content and format of applications, interpretation of FDA regulation, communication with the FDA and analysis of proposed rules. Liz also works with clients in the Cannabidiol space, offering strategic guidance and risk based strategies 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. She worked closely with FDLI members on current issues, such as FDA’s deeming regulations for tobacco products, the Drug Quality and Security Act, The Sunshine Act, and enforcement and advertising and promotional trends.

Elizabeth’s background includes research and consulting on veterinary medicine, new drug applications, generally recognized as safe (GRAS) determinations, and the FDA’s role in regulating marijuana.

As a law clerk, Elizabeth assisted with research and investigations for the House Judiciary Committee and Committee on Oversight and Government Reform on Capitol Hill. And as a student attorney, Elizabeth represented clients in custody and housing cases before the D.C. Superior Court.

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 and wrote and distributed legislative and regulatory updates. She also participated in the grassroots activities at the Business Industry Political Action Committee.

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.