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This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Silver Spring, MD.
This vacancy covers the Office of Scientific Investigations (OSI) and Office of Unapproved Drugs & Labeling Compliance (OUDLC), Silver Spring, MD.
The Office of Scientific Investigations (OSI) develops policies, surveillance activities, and compliance strategies relating to nonclinical and clinical drug product studies, bioequivalence studies, human subject protections, post-market Adverse Drug Experience reporting requirements, Risk Evaluation and Mitigation Strategies, and commitments for Postmarketing Requirements.
The Office of Unapproved Drugs & Labeling Compliance (OUDCL) develops policies and compliance strategies for protecting the public health by assuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-13-928126 under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
Who May Apply: Open to all United States Citizens.
This announcement may be used to fill additional vacancies.
The incumbent will serve as a Senior Regulatory Counsel resolving a broad range of legal/regulatory issues concerning the application of Food and Drug Administration's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the federal government.
Work with the team and the Division to develop and revise policies, programs, regulations, and guidance documents involving the most complex and highest priority matters affecting drug compliance.
Perform legal/regulatory reviews of petitions raising issues that have an industry-wide effect, as well as those that pertain to the marketing status of individual products.
Drafts and performs legal/regulatory reviews of action packages for enforcement actions, including Warning Letters and seizure and injunction referrals.
Make presentations at conferences and professional meetings in the U.S. and overseas before the regulated industry and the professional community on the applicable regulations and policies.