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Regulatory Counsel

Food and Drug Administration · Posted 60 days ago

Hybrid Silver Spring, MD $122K – $191K Apply by Jul 24, 2026 Miscellaneous Administration And Program ENTJESFJESTJISTJ
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About the Role

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 2 Band C.

What You'll Do

  • Drafts or critically reviews policy documents and program proposals and decisions on these products, including regulations, citizen petition responses, proposed legislation, and policy statements.
  • Reviews, summarizes, and drafts responses to all public comments received on proposed regulations, recommends adoption or rejection of counter-proposals contained in comments and objections, and drafts final regulations.
  • Prepares replies to correspondence from the regulated community, Congress, and other interested persons on issues that are industry-wide or have broad health implications and that concern precedent-setting interpretations of laws governing FDA policy Ensures that regulations and policies developed in the assigned areas are consistent with the statutory requirements and existing policy.
  • Serves as a regulatory resource in the statutes, regulations, policies, procedures, and implications relevant to the issuance of FDA regulations.
  • Petitions responses and conducts thorough analyses of complex regulatory and policy issues and provides advice to staff in CDER in carrying out its regulatory mission.

Requirements

  • Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required.
  • Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
  • TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements.
  • You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
  • Education must be accredited by an accrediting institution recognized by the U.S.
  • Department of Education in order for it to be credited towards qualifications.
  • Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S.
  • Department of Education.
  • If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.
  • Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file.
  • Therefore, you should consider asking the institution to provide the file in a non-secured electronic format.
  • Alternatively, you could scan or take a photo of the printed copy of the transcript.
  • If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.
  • For further information, visit the U.S.

Personality Fit

This role is commonly a great fit for these MBTI types:

Job ID: d645c58b-2dec-4e7d-95b5-1ce97e565c98

Posted via USAJobs

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