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

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Description

  • Duties

    Duties

    Summary

    Who May Apply (Detail): Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officers; individuals eligible for VRA appointments (at the GS-11 and below grade levels); and individuals with disabilities.

    PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

    ALL APPLICANTS MUST SUBMIT AN SF-50, CTAP, or COMMISSIONED CORPS DOCUMENTATION.

    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-DE-2021026 under competitive procedures. Please review that announcement to see if you are eligible for consideration under competitive procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.

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

    Responsibilities

    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

    No

    Promotion Potential

    15

    Who May Apply

    This job is open to...

    Status Candidates (Merit Promotion and VEOA Eligibles)

  • Job family (Series)

  • Requirements
  • Required Documents
  • Benefits
  • How to Apply
  • Fair & Transparent

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