Associate Commissioner for Regulatory Policy Coordination (Regulatory Counsel)

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

• 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.

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.

How to apply

In accordance with Executive Order 14170, applicants are encouraged to respond to the four short, free-response, essay questions in the questionnaire. Answers to these questions are optional and will not be scored or rated. Your answers will be reviewed by the hiring manager and agency leadership if you are referred for selection consideration. You will be asked to certify that your responses are written in your own words and that you did not use a consultant or artificial intelligence (AI) tool (such as ChatGPT or Copilot). 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. To apply for positions with the Food & Drug Administration, you must have a https://secure.login.gov/ account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 09/30/2026. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the close date. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://help.usajobs.gov/how-to. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Contact us at: USAJOBS - Contact us FDA's Applicant Help Desk is not able to support USAJOBS-related issues. The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: https://appsupport-usastaffing.opm.gov/hc/en-us. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis. If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 866-807-3742, or e-mail [email protected]. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 13059062 so that we may assist you faster. To preview the application questionnaire, click the link below. https://apply.usastaffing.gov/ViewQuestionnaire/13059062