Associate Commissioner for Regulatory Policy Coordination (Regulatory Counsel)

Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

• 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.

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 http://www.sss.gov 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.
• All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to random, reasonable suspicion, and post-accident drug testing upon hiring.
• Appointment to the position will be contingent upon a negative applicant drug test result.
• 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:

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)

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.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

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.

Resume: 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

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