Jill Hartzler Warner 2018-05-24T18:57:38+00:00

Vice President, Regulatory Policy


Jill Hartzler Warner, Vice President, Regulatory Policy, is an expert in strategic regulatory positioning, legal analysis, policy development, and problem solving in the context of international regulatory standards. From her 30-plus-year career at FDA, she brings her depth and breadth of experience and understanding of agency approaches gleaned from her many leadership roles at the agency, including Associate Commissioner, Senior Advisor, and Associate Chief Counsel.

During her vast and diverse career at FDA, Ms. Warner was responsible for executive oversight of the agency’s offices of orphan products development, combination products, pediatric therapeutics, good clinical practice, and advisory committee oversight and management. She provided key input on significant FDA legislation, including the 21st Century Cures Act, FDA Safety and Innovation Act, and FDA Modernization Act. As lead architect and author of FDA’s approach to cell and tissue product regulation, she brings significant expertise in regulation of regenerative medicine.

Ms. Warner successfully worked across FDA Centers and Divisions to craft solutions and pathways for innovative products. She served on many agency-wide working groups, and her experience spans diverse areas of the agency, including the Office of the Commissioner, Office of the Chief Counsel, Office of Medical Products and Tobacco, and the Center for Biologics and Evaluation and Research. Her work as FDA’s representative to the World Health Association and the Institute of Medicine fostered collaborative partnerships in tackling issues such as cell and tissue regulation and addressing conflicts of interest in medical product development.

She received numerous awards during her FDA career, including: the HHS Secretary’s Award for Distinguished Service for outstanding performance in developing and finalizing a major rulemaking to implement a comprehensive regulatory approach for enhanced safety of human cells, tissues, and cellular and tissue-based products; and the FDA Commissioner’s Special Citation for helping to bring about the successful passage of the FDA Safety and Innovation Act in 2012.

Ms. Warner received both her JD and BA from the University of Virginia.

NANCY BRADISH MYERS President/Founder

JILL HARTZLER WARNER, JD

Vice President, Regulatory Policy


About Jill

She received both her JD and BA from the University of Virginia.

Ms. Warner is a former FDA Associate Commissioner, Senior Advisor, and Associate Chief Counsel.  She brings a depth and breadth of experience and understanding of agency approaches based on many leadership roles over 30+ years at FDA. During her time at the agency, she was responsible for executive oversight of the agencys offices of orphan products development, combination products, pediatric therapeutics, good clinical practice, and advisory committee oversight and management. She provided key input on significant FDA legislation, including the 21st Century Cures Act, FDA Safety and Innovation Act, and FDA Modernization Act.  She also brings significant expertise in regulation of regenerative medicine as lead architect and author of FDAs approach to cell and tissue product regulation.