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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 7, Band E. Responsibilities Serves as the Agency's lead on all matters related to issuance of Food and Drug Administration (FDA) documents in the Federal Register. Coordinates clearance and publication and ensuring that regulations and other documents meet applicable Federal Register requirements. Serves as a principal liaison to policy staff within FDA; at DHHS; to the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB). Serves as a principal liaison to the Office of the Federal Register (OFR) regarding Federal Register documents and regulatory planning activities. Performs the administrative and personnel management functions of supervising staff. Requirements Conditions of Employment Qualifications Introduction: The 21st Century Cures Act ("Cures" or The Act) grants the HHS/FDA the authority to appoint outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. Such positions shall be within the competitive service. Candidates will be appointed and compensated without regard to Title 5 of the United States Code (U.S.C.) governing appointment in the competitive service. The Act further states the Commissioner of FDA may determine and set (1) the annual rate of pay of any individual appointed; (2) the annual rate of pay for any qualified scientific, technical, or professional personnel appointed to a position before the date of enactment of the 21st Century Cures Act. Based on the Act, it allows the FDA the authority to create and administer its own Alternative Pay System (APS) to recruit and retain qualified scientific, technical, or professional candidates to carry out mission-critical functions. In order to qualify for the Supervisory Regulatory Policy Analyst position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/01/2024: Title 21 CURES Relevant Experience for Supervisory Regulatory Policy Analyst, AD-0301-00, Band E level: You must have 9 years of relevant experience providing leadership and oversight of a regulatory program; serving as an advisor and technical expert to senior-level government officials or executives outside of government on regulatory policies and procedures, legislation, or technical matters that affect policy issues; and performing administrative and personnel management functions of supervising. Education EDUCATIONAL SUBSTITUTION: There is no educational substitution for this position. 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. Student Loan Repayment authorized: Yes Financial disclosure statement, OGE-450, required: Please be advised that this position may be 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. This position may require 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. Additional Information: Additional selections may be made for similar positions across the Food and Drug Administration (FDA) within the local commuting area(s) of the location identified in this 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 07/01/2024) 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. 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 (07/01/2024); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.