Attorney/Scientist focused on FDA policy development
Senior Regulatory Affairs and Compliance Attorney delivering critical legal and policy guidance to executives on requirements governing an array of cosmetics, devices, and biological products. Gained progressive responsibility at FDA, advancing from pre-IND/IND Reviewer to Regulatory Counsel and ultimately Associate Director for Policy leading a regulatory policy and compliance team.
Food and Drug Administration (FDA), Office of the Chief Scientist/Office of the Commissioner
Maryland
Rapidly advanced to manage a regulatory policy and compliance team implementing the Modernization of Cosmetics Regulation Act of 2022, and supporting the office’s cross-cutting initiatives.
Food and Drug Administration (FDA), Office of Counter-terrorism and Emerging Threats/Office of the Chief Scientist/Office of the Commissioner
Maryland
Advised on emergency use authorities and guided clearance of emergency use authorizations (EUAs) for medical devices, working closely with the Center for Devices and Radiological Health and Office of the Chief Counsel to facilitate the availability of products for the U.S. population.
Food and Drug Administration (FDA), Office of the Center Director/Center for Biologics Evaluation and Research (CBER)
Maryland
Rapidly promoted to lead CBER’s implementation of the pediatric and safety provisions of the FDA Amendments Act of 2007.
Drafted, reviewed and resolved comments on policy documents regarding pharmaceuticals and devices to shape regulatory policy and support management’s decision making/clearance; functionally served as special assistant to CBER’s Associate Director for Policy.
Food and Drug Administration (FDA), Division of Vaccines and Related Products Applications/Office of Vaccines Research and Review/CBER
Maryland
Managed review of regulatory submissions (pre-IND, IND, sBLA) for live biotherapeutic products and allergenic extracts to help ensure the safety of human subjects in clinical trials.
Developed regulatory policy and led issuance of guidance for industry on chemistry, manufacturing, and controls (CMC) information for early development of live biotherapeutic products to help improve the quality of regulatory submissions.