Summary

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 5, Band G.

Duties

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• Works with the Commissioner, Deputy Commissioners, and senior executives on regulatory policy; co-formulates Agency policy and philosophy; interprets Commissioner directives; and makes broad program decisions, escalating only critical issues.
• Advises the Commissioner, Principal Deputy Commissioner, and Deputy Commissioner for OPLIA on major management decisions involving potentially controversial or high-impact issues.
• Leads staff overseeing Agency-wide rulemaking and regulations development; ensures high-quality, timely regulations that advance the Agency's mission; and sets priorities while focusing resources effectively.
• Dedicates significant effort to promulgating regulations, securing Department and OMA clearances, and communicating their public health impact to media, Congress, industry, and the public.
• Directs the communication of policies and program decisions to the organizational elements of the Agency over which the Associate Commissioner for Policy exercises executive direction and to outside groups affected by FDA regulatory policy.
• Evaluates program effectiveness, directs studies to address deficiencies, and makes decisions on organizational and staffing plans and delegations of authority consistent with Commissioner guidelines and Agency needs.
• Serves as the Commissioner's representative and spokesperson, clearly and timely communicating FDA policy direction and regulatory responsibilities to outside groups.
• Executes special assignments for the Deputy Commissioner for OPLIA, engaging high-level officials across HHS, the Administration, Congress, State and foreign governments, industry, and academic and public health communities.
• Builds cooperative relationships with FDA Centers and Offices to ensure consistent policy and rulemaking approaches and Agency-wide program alignment.
• Performs other duties as assigned.

Requirements

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Conditions of employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.

Qualifications

In order to qualify for the Associate Commissioner for Regulatory Policy Coordination (Regulatory Counsel) position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 09/30/2026:

The candidate must meet the following qualifications for this Title 21 position:

1. Scientific, Technical, and/or Professional Fields
2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions

b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

To be qualified for the Associate Commissioner for Regulatory Policy Coordination (Regulatory Counsel), AD-0301, Band G position you must meet the following qualification and it must be evident within your 2-page resume or you must submit transcripts if you are qualifying based on education:

Education: A law degree, specifically a LL.M. or J.D.. The degree must be from a accredited program or institution. (You must submit transcripts to support your claim)

OR

Experience: Comparable regulatory experience focused on interpreting laws, rules, regulations, or policies; or develop or analyze regulations and policies for regulated products. (This experience must be reflected in your 2-page resume)

Active-duty U.S. Public Health Service Commissioned Corps Officers are encouraged to apply. If selected, officers may either (1) remain on active duty assigned to the designated billet for PHS assignment, or (2) separate or retire from the Commissioned Corps before entering a Title 21 civilian appointment.

This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes.

Supervisor Responsibilities: The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources. Performance and accomplishments are assessed primarily through work performance indicators, staff discussion, planning sessions, review of individual project outputs, and annual program review. Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences. Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities. Demonstrates high integrity and adheres to the highest ethical standards of public service. Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication. Takes a leadership role in advocating for and advancing the priorities of the Agency. Serves as a role model for leadership by encouraging teamwork and a collaborative approach. Timely notifies Agency officials of all significant actions and developments, including but not limited to those related to regulatory matters, legislative matters, budget matters, reports, initiatives, and events and ensures subordinate managers do the same.

Provides reasonable accommodations needed to best utilize qualified people with disabilities.

Background Investigation/Security Clearance Requirements: Non-Sensitive/High Risk (Public Trust)

Education

If you are qualifying based on the education qualification listed above you must submit transcripts, the education must be the following: A law degree, specifically a LL.M. or J.D.. The degree must be from a accredited program or institution.

Additional information

Additional Conditions of Employment:

• Pre-employment physical required: No
• Drug testing required: No
• License required: No
• Mobility agreement required: No
• Immunization required: No
• Bargaining Unit: No
• Telework eligible position: Telework is at the discretion of the supervisor.

• Financial disclosure statement, SF-278, required: Please be advised that this position is subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position

Additional Information:

• Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement.
• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
• If you are serving, or have served in the last 5 years (from 09/30/2026) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more.
• Ethics Clearance Requirements
  This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

All requirements must be met by the closing date of this announcement (09/30/2026); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

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Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Benefits

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A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.

Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.