Summary The position is located in the Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products (CTP), Office of Regulations (OR). The incumbent assists with ensuring that regulations and policies developed in the area of tobacco products are consistent with statutory requirements and existing policy. Responsibilities Performs research on regulatory issues and provide recommendations to revise existing or to create new policies and/or regulations. Reviews proposals and make recommendations for new guidance documents that affect regulatory activities. Assists in the development of programs involving matters affecting the regulation of the tobacco industry. Assists in drafting replies to correspondence from the regulated community and other interested persons on issues that effect one or more portions of the regulated industry. Participates in the development of regulations, petition responses, and other written statements of agency policy. Communicates current policies applicable to a regulated industry, clinical investigators and medical/scientific community. Requirements Conditions of Employment Qualifications Applicants must meet the following eligibility requirements to participate in this Recent Graduate Program: A. Completed all requirements for an associates, bachelors, masters, professional, doctorate, vocational, or technical degree or qualifying certificate from an accredited educational institution within the 2 years preceding the closing date of this announcement. -OR- B. Released or discharged from active duty within the previous two years by 11/18/2024, where as a veteran who, due to a military service obligation, was precluded from applying to the Recent Graduate Program during any portion of the 2-year eligibility period following completion of degree or certificate requirements, are entitled to a full 2-year period of eligibility upon release or discharge from active duty. In no event, however, may the eligibility period extend beyond 6 years from the date on which the preference eligible veteran completed the requirements of the degree or certificate. -OR- C. Individuals who are expected to graduate with a qualifying Associate's, Bachelor's, Master's, Doctorate, professional, vocational or technical degree or certificate program by December 31, 2024. Current students must meet all eligibility and qualification requirements before a final offer can be made. NOTE: You must submit transcripts or official documentation to verify your eligibility under the Recent Graduate Program. Transcripts MUST reflect the degree/certificate program and the degree conferred date. If your degree/certificate has not been conferred, you must provide proof of the anticipated graduation date. Selectee's entry on duty date will be upon degree conferment. In addition to the eligibility requirements for the Pathways Recent Graduate Program, you must also meet the following OPM Qualification Requirements listed below by 11/18/2024 in order to qualify for the Regulatory Counsel, 0301, at GS - 9. For GS-9: A. Applicants must have at least one full year of specialized experience, equivalent to the GS-07 grade level in the Federal service which includes in researching regulatory issues and providing recommendations to revise existing or create new policies, procedures and/or programs; drafting correspondence regarding policies, procedures and/or other process documents. -OR- B. Have completed a Master's or equivalent graduate degree, or 2 full years of progressively higher-level graduate education leading to such a degree, or LL.B. or J.D. that is related to the position to be filled. -OR- C. Have a combination of specialized experience as described in "A" above and graduate education as described in "B" above. To combine education and experience, determine the applicant's total qualifying experience as a percentage of the experience required for the grade level. Then determine the applicant's education as a percentage of the education required for the grade level. Finally, add the two percentages. The total percentage must equal at least 100 percent to quality. Note: One year of full-time graduate education is considered to be the number of credit hours that the school you attended has determined to represent one year of study. If this information cannot be obtained from your school, we will consider 18 semester/27 quarter hours to be equal to one year of full-time study. This position requires a degree or completion of specific courses in order to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Your transcript(s) must clearly demonstrate the course(s) listed in the Basic Qualification requirement section. If the transcript(s) does not clearly demonstrate this, you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met by the closing date of this job announcement and your transcript(s) submitted must reflect this. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJBS Resume Builder to develop their federal resume. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Education FOREIGN EDUCATION Foreign Education is education acquired outside of any State of the U.S., the District of Columbia, the Commonwealth of Puerto Rico, a Trust Territory of the Pacific Islands, or any territory or possession of the U.S. Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential 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 SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. 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. 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. Additional Information More information on the Pathways Programs for Recent Graduates can be found at: https://www.opm.gov/policy-data-oversight/hiring-information/students-recent-graduates/. The Pathways Recent Graduates may be non-competitively converted to a term, career-conditional, or career appointment following successful completion of at least one year of continuous service, demonstrated successful job performance, and after meeting all other qualification requirements in accordance with 5 CFR 362.305. To be eligible for conversion to a permanent or term position, Recent Graduates must: Successfully completed at least 1-year of continuous service in addition to all requirements of the Program. Received a performance rating of at least "Achieved Expected Results". Meet the Office of Personnel Management's qualifications for the position to which the Recent Graduate will be converted. Received a written favorable recommendation for conversion by his/her first-level supervisor. Positions will require 40 hours of formal training per year. Must be a citizen of the United States. ADDITIONAL CONDITIONS OF EMPLOYMENT: If you are serving, or have served in the last 5 years (from 11/18/2024) 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. Political Appointee FAQ - OPM 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. Financial disclosure statement, OGE-450: 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. Pre-employment physical required: No Drug testing required: No License required: No Mobility agreement required: No Immunization required: No Annual leave for non-federal service authorized: No Bargaining Unit Position: Yes, 3591 - National Treasury Employees Union (NTEU). Additional selections may be made.