U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of Regulatory Affairs
  5. Anne E. Johnson, Senior Science Advisor
  1. Office of Regulatory Affairs

Anne E. Johnson, Senior Science Advisor

Blue Bar

Anne Johnson

Anne E. Johnson is the Senior Science Advisor to the Associate Commissioner for Regulatory Affairs (ACRA) within the Office of Regulatory Affairs (ORA) in the U.S. Food and Drug Administration (FDA). She serves as principal advisor to the ACRA, Deputy Associate Commissioner for Regulatory Affairs, and Senior Executive Team on regulatory matters, policy development, nationwide program execution, and short- and long-range program goals. She directly oversees enterprise-wide and cross-cutting operational plans and initiatives for carrying out ORA’s public health activities and represents the ACRA in coordinating and establishing the agency position on selected policies, issues, and program objectives. 

Ms. Johnson assumed the role of Senior Science Advisor in May 2024. Prior to this appointment, she served as Director of ORA’s Office of Bioresearch Monitoring Operations, Eastern Division, where she directed field inspectional operations covering clinical and non-clinical research of medical products and foods, post-marketing pharmacovigilance and select pre-approval tobacco programs designed to ensure human subject protection, evaluate data quality and integrity in product approval applications, and assess industry conformance with laws and regulations.  

She began her FDA career as an investigator performing inspections across all commodities, with a focus on drug manufacturing, blood banking, and sterile manufacturing processes. Later, she was competitively selected as a blood bank specialist. In ensuing years, she held multiple positions within ORA related to Team Biologics compliance and enforcement and regulatory follow-up in with respect to biologics, biotech drugs, and biological device industries worldwide. She also served as supervisory investigator of an interdisciplinary team in a role that required management of state contracts, and as Deputy District Director/District Director directing all field agency operations within the states of Pennsylvania and Delaware. Her career highlights include executive quality experience developing and implementing operational, tactical, and policy-focused strategies for a geographically dispersed, diverse workforce with a global public health mission. In these various capacities she has led within cross-functional, multi-disciplinary FDA investigative, compliance, and regulatory operational areas, with advanced specialized expertise in medical products, bioresearch monitoring, incident command, recalls, consumer complaints, work planning, and emergency preparedness and response.

Ms. Johnson is active on the speaking circuit, presenting at conferences for regulators, industry, academia, and stakeholders. She is an FDA mentor and has chaired several agency-wide committees, holding leadership experience on interagency efforts such as National Special Security Events and Rapid Response Teams. She is also chair of the Philadelphia Federal Executive Board. She holds a bachelor’s degree in chemistry from Rutgers University, a Certificate in Music and Fine Arts from Regent University, and is a graduate of the Federal Executive Institute with a Certificate of Mastery in Leadership.

 Back to all ORA SET Members

Related Links

Back to Top