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U.S. Department of Health and Human Services

About FDA

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Regulatory Counsel


Description of Duties at GS-13 level:

  • Conducts analyses of complex legal and policy issues to advise staff in the FDA's Center for Drug Evaluation and Research in carrying out its regulatory mission.
  • Works with scientific, regulatory, and legal experts to develop policies, regulations, and documents pertaining to the regulation of drug products.
  • Reviews, drafts, and comments on responses to citizen petitions, regulations, guidances, legislation, pleadings, policy documents, and legal or other correspondence on matters pertaining to FDA's jurisdiction.
  • Provides advice and guidance to regulatory specialists and other professionals within FDA.

Description of duties at GS-14 level:

  •  Conducts sophisticated analyses of complex legal and policy issues to advise staff in the FDA's Center for Drug Evaluation and Research in carrying out its regulatory mission.
  • Works with scientific, regulatory, and legal experts to develop policies, regulations, and documents pertaining to the regulation of drug products.
  • Reviews, drafts, and comments on responses to citizen petitions, regulations, guidances, legislation, pleadings, policy documents,  and legal or other correspondence on matters pertaining to FDA's jurisdiction.
  •  Provides advice, guidance, and training to more junior Regulatory Counsels, regulatory specialists, and other professionals within FDA.

Qualifications

To qualify for the GS-13, you must have at least one year of specialized experience equivalent to the GS-12 in the Federal service that included interpreting statutes and regulations affecting technical regulatory programs such as food and drug, healthcare, environmental, or other complex technical regulatory programs and drafting legal documents such as pleadings in court, briefs, legal opinions, and legal memoranda.

To qualify for the GS-14, you must have at least one full year of specialized experience (equivalent to the GS-13 grade level or higher in the Federal service) that included analyzing, evaluating, and applying complex statutes and regulations affecting technical regulatory programs such as food and drug, healthcare, environmental, or other complex technical regulatory programs; drafting legal documents such as pleadings in court, briefs, legal opinions, and legal memoranda; and participating in working groups of scientific, regulatory, and legal experts to develop recommendations.

Grade (Salary) Level

Federal General Schedule (GS) grade levels at which regulatory counsel positions are commonly filled are:

  • GS-13 through GS-14