Associate Commissioner for Regulatory Policy Coordination (Regulatory Counsel)

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 5, Band G.

What you will do

• 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.

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.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above. This is a Title 21 announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test.

Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Documents you must provide

• At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed.
• A CV (curriculum vitae) may not contain enough information to meet these resume requirements.
• USAJobs - What to Include USAJobs - Page Limit Your two (2) page RESUME showing all relevant work experience (paid and unpaid) including: duties performed; full name and address of each employer; start and end dates (month/day/year); work schedule (part-time, full-time, number of hours if intermittent); salary; and any completed education and training (program title, subject area, number of hours completed, and completion date).
• Transcripts (if applicable): If you are qualifying based on education, you must submit transcripts.
• Additional Documents (if applicable): Cover Letter Other supporting documentation not listed above Resume SF-50/ Notification of Personnel Action Transcript Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

What to expect next

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. You will receive application status updates via email and via USAJOBS as the process unfolds. Your feedback matters.

Please complete this brief survey and let us know how we are doing.

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: ***

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.

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.