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Associate Commissioner for Regulatory Policy Coordination (Regulatory Counsel)

Food And Drug Administration

Job Location:

Silver Spring, MD - USA

Yearly Salary: USD 213491 - 213491

Posted: 6 October 2026 (3 days ago)

Application Deadline: 3 January 2027

Vacancies: 1 Vacancy

Job Summary

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.

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Duties

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 Agencys 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 Commissioners 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

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.
FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises you must take affirmative steps to resolve the matter.
Males born after December 31 1959 must be registered with the Selective Service. Please go to for more information.
Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired you may be subject to additional investigations at a later time.
Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration non-selection or appropriate legal action.
Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
Ethics Clearance and Financial Disclosure is required.

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:

Scientific Technical and/or Professional Fields
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)

This is not a Testing Designated Position. Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.

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 FDAs 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 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 FDAs 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: selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.

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.

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.

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.

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