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.

Duties

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

• 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.
• One-year probationary period may be required.
• Financial Disclosure may be required.
• Ethics Clearance may be required.
• 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.
• One-year supervisory probationary period may be required.

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.

Contacts

• Address FDA Office of the Commissioner 10903 New Hampshire Ave Silver Spring, MD 20993 US
• Name: FDA Applicant Help Desk
• Phone: 866-807-3742
• Email: [email protected]