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As a Regulatory Counsel in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigation (OSI) or Office of Unapproved Drugs and Labeling Compliance (OUDLC), you will serve as a legal/regulatory expert resolving a broad range of legal/regulatory issues concerning the application of FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-MP-14-1048589TM 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.
This job opportunity announcement may be used FDA-wide to fill additional vacancies within the same geographical location.
- Develops and revises regulations and guidance, advising on compliance with FDA's Good Guidance Practice regulations and other legal/regulatory issues.
- Reviews and drafts policy proposals and decisions.
- Performs legal/regulatory reviews of petitions raising issues with industry-wide effect.
- Provides technical guidance on procedures and methods involved in implementing new programs, guidance, and regulations.
- Informs management and staff on new or revised regulations, internal policies and procedures, and trends in the pharmaceutical and health care industry.
- Ensures legal/regulatory sufficiency of action packages for regulatory enforcement actions.
- Drafts/reviews proposals for new regulations and policy statements.