Help Duties Provide supporting information and evidence regarding the extent and seriousness of violations, and the acceptability of voluntary corrective actions. Provide information and guidance to foreign government counterparts or entities, U.S. Federal Agencies, private industry, and academia on unique and complex regulatory issues. Conduct inspections of new or unusual commodities and manufacturing practices, and devises needed innovations, methodologies, and modifications to the inspectional approach. Prepare correspondence, technical reports, estimates, fact sheets, status reports, and schedules to complete project assignments. Independently acts upon a full range of violations, including those involving emergency situations, lack of precedents or guidelines, ambiguous or dubious evidence, and/or uncooperative industry officials. Develop formal training programs that provide training and instruction to agency employees and State and local government personnel regarding inspection and investigative techniques; regulatory policies, standards, and requirements; and other compliance and enforcement matters. Serve as a foreign post focal point in conducting investigations of the most complex, controversial, and precedent setting scientific and regulatory problems involving industry practices and products within the specialty area. Provide expert technical guidance to management for strategic planning and program development. Serve on working groups to develop critical guidance for industry pertaining to the manufacture of FDA regulated products. Requirements 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 Temporary or Term appointment within the excepted service and does not provide permanent placement upon completion or termination of the overseas assignment. 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. 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. A Secret Clearance is required for India. Selectees for temporary/term assignments may begin and remain stateside until all required clearances and trainings (security, medical and applicable trainings) are completed before being deployed to an overseas location. A Statement of Understanding is required to be signed by the selected candidate indicating they understand the terms and conditions of this temporary appointment. 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 06/13/2025 : Basic Qualification Requirements: Applicants must meet one of the following requirements: Education: 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 Experience: 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, scaleup, 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. 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 (transcript required) and also have 3 or more years of 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: (1) Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; (2) Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; (3) Product development, process development, scale-up, or commercial manufacturing; and/or, (4) Sterility assurance and microbiological controls. OR Have a master's degree (transcript required) and also have 2 or more years of 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: (1) Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; (2) Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; (3) Product development, process development, scale-up, or commercial manufacturing; and/or, (4) Sterility assurance and microbiological controls. OR Have a Doctorate and/or J.D. degree (transcript required) and also have 1 or more years of 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: (1) Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; (2) Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; (3) Product development, process development, scale-up, or commercial manufacturing; and/or, (4) Sterility assurance and microbiological controls. OR Have 5 or more years of 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: (1) Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates; (2) Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity; (3) Product development, process development, scale-up, or commercial manufacturing; and/or, (4) Sterility assurance and microbiological controls. 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 Additional Conditions of Employment: Pre-employment physical required: No Drug testing required: Yes License required: No Mobility agreement required: No Immunization required: No Bargaining Unit: No Telework eligible position: No 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 06/13/2025) 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 ( 06/13/2025 ); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process. Read more Show more Show less
