The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

The Office of Regulatory Policy (ORP), Divisions of Regulatory Policy I-IV (DRP I-IV), initiates, develops, and reviews regulations, policies, procedures, and guidance that affect the regulation of drugs under the Federal Food, Drug, and Cosmetic Act. DRP serves as the Center's focal point on regulatory issues and provides advice and assistance on the scope, applicability, and meaning of the Federal Food, Drug, and Cosmetic Act, other laws, regulations, and policies.

Duties/Responsibilities

The incumbent serves as a Regulatory Counsel in DRP I-IV. The work includes writing regulations; preparing responses to citizen petitions, petitions for stay of action, and/or petitions for reconsideration; drafting and commenting on legislation; and providing advice on the interpretation of laws, regulations, and policies applicable to FDA.

• Conducts sophisticated analyses of complex regulatory and policy issues and provides advice to staff in the Center for Drug Evaluation and Research in carrying out its regulatory mission.
• Provides technical advice and guidance to more junior Regulatory Counsels.
• Handles complex and difficult assignments of national scope and significance.
• Assumes primary responsibility for ensuring that regulations and policies developed in the assigned areas are consistent with the statutory requirements and existing policy, that their need is justified, and that they are adequately supported by appropriate analysis including adequate scientific and medical analyses when required.
• Develops policies and programs involving complex and high-priority matters affecting the regulation of drug products, including regulations, citizen petition responses, proposed legislation, and policy statements.
• Conducts legal, regulatory, and policy research using resources such as Westlaw, LexisNexis, MediRegs, the U.S. Code, the Code of Federal Regulations, and the Federal Register.
• Leads working groups of scientific, regulatory, and subject matter experts to develop new or revised regulations and draft resulting notices of proposed rulemaking.
• Reviews, summarizes, and drafts responses to public comments on proposed regulations; recommends adoption or rejection of counter-proposals; and drafts final regulations.
• Prepares replies to correspondence from the regulated community, Congress, and other interested persons on issues that are industry-wide in scope or have broad health implications.
• Consults with scientific experts and drafts responses to citizen petitions, petitions for stay of action, and/or petitions for reconsideration.
• Drafts and comments on proposed legislation on matters pertaining to FDA jurisdiction.
• Advises Center offices on implementing new regulations, revising existing regulations, and assessing proposed policy statements and policy initiatives.
• Provides guidance and/or training to regulatory specialists and other professionals within FDA.
• Advises staff in the FDA Office of Chief Counsel and other Office of the Commissioner offices on matters related to the position.
• Consults with staff at all levels of the Agency to identify and resolve policy disagreements and articulate policy consensus through decision memoranda, meetings, regulations, petition responses, or other written statements of agency policy.

How to Apply

Submit resume or curriculum vitae with cover letter and transcript(s) by (Date) to: oo-talent-coordination-staff-division-i-actions@fda.hhs.gov. Candidate resumes may be shared with hiring official within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share.”

Please reference Job Reference ID: FY26-CDER-Vacancy Announcement-565

Announcement Contact

For questions regarding this Title 21 position, please contact oo-talent-coordination-staff-division-i-actions@fda.hhs.gov.

Qualifications

To be placed into a Title 21 position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields
2. Qualified and Outstanding Candidates
   1. Qualified applies to all candidates for Title 21 appointments. The FDA OTS will use the basic requirements defined in the applicable Title 21 Job Family or OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
   2. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications.

Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Education Requirement: A law degree, specifically a LL.M. or J.D. The degree must be from an accredited program or institution.

OR

Comparable regulatory experience focused oninterpreting laws, rules, regulations, or policies; or develop oranalyze regulations and policies for regulated products.

Professional Experience: Provides analyses and advice on the interpretation of laws, regulations, and policies and guidance applicable for FDA regulated products. Participates or provides leadership in the development, implementation, and evaluation of regulations and policies as they relate to the Agency's programs and activities to ensure the safety, efficacy, and quality of FDA regulated products.

In addition to meeting the basic requirements outlined above, applicants must also meet the following minimum years of experience requirements:

• Have a Law Degree (LL.M. or J.D.) and at least 2 years of relevant comparable work experience

Desired Education: The ideal candidate will possess a Juris Doctorate degree from an accredited institution of higher learning.

Desired Professional Experience:

• Knowledge of federal regulatory programs.
• Knowledge of regulatory practice, policies, and procedures.
• Ability to identify and analyze problems; weigh relevance and accuracy of information; generate and evaluate alternatives; and make recommendations.
• Ability to communicate orally and in writing and work with staff at all levels of the organization and with varying levels of domain expertise.
• Ability to collaborate across boundaries to build strategic relationships and achieve common goals.
• Ability to work independently and as a contributing collaborative team member.
• Ability to organize time effectively, determine priorities, and move work forward.
• Experience developing, critically reviewing, or advising on regulations, citizen petition responses, proposed legislation, policy statements, regulatory guidance, or similar documents affecting drug regulation.
• Experience leading or contributing to cross-functional working groups addressing complex, controversial, high-priority regulatory and policy issues.

Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

About FDA

The Food and Drug Administration’s (FDA) mission is to protect and advance public health by helping to speed innovations that provide our nation with safe and effective medical products and that keep our food safe and reduce harm from all regulated tobacco products.

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