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Supervisory Regulatory Affairs Advisor at U.S. Food & Drug Administration in Silver Spring, MD

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  • Duties



    This position is located in the Department of Health and Human Services, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office Generic Drug Policy (OGDP), Division of Legal & Regulatory support (DLRS) located in Silver Spring, MD.

    This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-18-MP-2021021under 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.

    Additional selections may be made within the same geographical area FDA-wide.


    As a Supervisory Regulatory Affairs Advisor: you will have the following responsibilities:

    1. The Division Director is responsible for management and direction of a professional, highly trained technical staff involved in the development and implementation of policies that are consistent with statutory and regulatory, requirements and existing policies.

    2. Coordinate and evaluate the division's overall legal and regulatory efforts.

    3. Resolve a range of issues concerning the application of FDA-related legislation, pertinent regulation, and/or general legislation related to generic drugs.

    4. Initiate decision-making process and documents, and participate fully in discussions, and decisions concerning Office of Generic Drug plans, programs, and activities in strategic planning and in the determination, allocation, and administration of Center program segments, functions, and activities.

    5. Supervise regulatory counsels and other subordinate staff in handling highly complex and difficult assignments of national and international scope and significance.

    6. Participate in conferences, meetings, hearings, and presentations involving problems and issues of considerable consequence and importance to the mission of the Division.

    7. Ensure regulations and policies are developed and/or applied in the assigned area that are consistent with statutory and regulatory requirements and have adequate scientific and medical support where applicable.

    Travel Required

    Not required

    Supervisory status


    Promotion Potential


    Who May Apply

    This job is open to...

    United States Citizens

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