As Senior Vice President, Regulatory Policy and Intelligence, Meredith handles regulatory policy, intelligence, and strategy with a focus on guiding clients through complex regulatory frameworks and policy challenges throughout the drug development lifecycle.

Meredith’s experience spans two decades at FDA, where she served in a number of leadership roles across FDA’s Center for Drug Evaluation and Research including, most recently, as an Associate Director in the Office of New Drugs. There she provided advice and counsel regarding a wide range of critical cross-cutting issues and initiatives associated with drug product development. Meredith has extensive expertise working directly with OND review teams and leadership to resolve complex and often novel issues and she is one of a handful of attorneys ever to have worked directly within OND. Prior to her time in OND, Meredith served as a Deputy Director in CDER’s Office of Compliance, where she lead an office on matters pertaining to supply chain security, imports and exports, recalls and shortages, and incidents involving serious adverse events. Her role involved resolving complex and controversial drug product compliance matters and major public health crises associated with CDER-regulated products. She also served in a variety of other capacities during her tenure at FDA, including as a Regulatory Counsel in the Office of Compliance and in the Office of Regulatory Policy working on legal, regulatory, and policy issues across the Agency.

Meredith now partners with life sciences organizations to help understand and navigate the evolving legal and regulatory landscape and bring therapies to market. Meredith is known for making complex legal and regulatory requirements accessible and for creative problem-solving. Her extensive knowledge of FDA law and regulations, combined with firsthand experience resolving legal and regulatory issues, enables her to deliver strategic, actionable solutions that align with evolving FDA expectations and support product advancement and business success. Her diverse legal background, combined with deep FDA institutional knowledge, makes her a trusted advisor to clients seeking practical, informed, and strategic solutions in today’s evolving regulatory environment.