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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 1, Band C. Responsibilities Reviews recommendations for potential administrative and judicial actions based on adulteration charges under the Food Drug and Cosmetic (FD and C) Act to ensure consistency and adherence to FDA policy. Provides enforcement decision and compliance strategies based on review of evidence of violations, compliance policy, public health risks, and availability. Reviews inspection reports submitted by field investigators and other information and data to determine compliance with applicable laws and regulations. Responsible for implementing and managing a full range of compliance actions, both administrative and judicial, including casework and related functional responsibilities in the area of human foods. Provides scientific and technical input on compliance issues and in regulatory meetings to ensure consistency of interpretation of Current Good Manufacturing Practices (CGMPs) and other foods regulations. Leads or participates in cross-functional working groups, regulatory task forces, and agency-wide initiatives focused on enhancing program effectiveness, developing enforcement policies, and improving national compliance outcomes. Evaluates, identifies, and addresses significant problems and issues in areas where nominal policy guidance exists, and requires prompt remediation. Writes technical reports or completes technical analyses based on inspectional and sampling findings of foods and/or dietary supplements and makes recommendations for further action. Provides an accurate assessment of the state of compliance of a firm or corporation on regulatory compliance and enforcement. Perform other duties as assigned. Requirements Conditions of Employment Qualifications In order to qualify for the Regulatory Specialist position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/23/2025: Basic Qualification Requirements: Have a bachelor's degree or higher in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field. The degree must be from an accredited program or institution. OR Have comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates. Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity. Product development, process development, scale-up, or commercial manufacturing. Sterility assurance and microbiological controls. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. AND IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. Have a bachelor's degree and have 4 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a master's degree and have 3 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a Doctorate and/or J.D. degree and have 1 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a MD, DO, DDS, DPM, or DVM degree and have 0 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have 6 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. Education Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. See the Application Manager Documentation for tips on submitting your paper-based documents. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation. Additional Information The application limit, if applicable, for this advertisement is: No Limit. 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: N/A Telework eligible position: Telework is at the discretion of the supervisor. 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 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 07/23/2025) 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 (07/23/2025); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.