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Summary This position is located in the Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs, Office of Partnerships and Operational Policy, Office of Policy, Compliance, and Enforcement, Division of Operational Policy. This position assists senior specialist(s) in assignments of national scope and significance and in developing regulations and policies as assigned that are consistent with statutory requirements and existing policy. Responsibilities Drafts or reviews proposals for new regulations and policy statements involving the area of regulatory expertise. Consults with staff at all levels of the ORA and identifies areas of disagreement within the ORA or between the ORA and other units of FDA. Resolves disagreements through the use of decision memoranda or through meetings and articulates any policy consensus reached through this process. Develops policies and programs involving matters affecting the regulation of office program responsibility. Performs duties that include resolving a broad range of issues concerning the application of any of FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government. Researches regulatory issues and revising existing or creating new policies and regulations. Requirements Conditions of Employment Qualifications The position of Regulatory Counsel falls within the 0301 occupational series. To qualify for this position at grade GS-12, you must meet Time-in-Grade requirements by 11:59 pm EST on 07/17/2024. Time-in-Grade: Any individual who is currently holding, or has held within the previous 52 weeks, a General Schedule position under non-temporary appointment in the competitive or excepted service, must meet time-in-grade requirements (must have served 52 weeks at the next lower grade or equivalent in the Federal service). Time-in-grade requirements must be met by the closing date of this announcement. For this vacancy, applicants must have held grade GS-11 or higher for at least one year to be eligible for the GS-12 grade level. The grade must have been held in the Federal service but may have been in any occupation. Minimum Qualifications: Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. The specialized experience must demonstrate one year of full-time work experience , or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. GS-12: You must have 1 year of specialized experience equivalent to at least the GS-11, in the Federal service, which includes: developing, planning, analyzing and researching issues to evaluate the effect of laws and regulations; reviewing and modifying policy and/or procedures to promote the efficiency and effectiveness of programs; providing policy analysis and critical review of issues affecting regulated products; reviewing and drafting legal documents, including proposed and final policies, regulations, and guidance. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above. PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment. NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account,https://secure.login.gov/ select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process. 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 USAJOBS 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. You must submit supporting documentation to verify your eligibility to apply for this vacancy. For internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question. See the Required Documents section for full details... Education There is no education substitution for experience at the GS-12 grade level. Additional Information For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest, FDA reserves the option of setting an application number limit. When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either: (A) the day the limit is reached, -OR- (B) the pre-defined closing date of 07/17/2024, whichever comes first. If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET. The application limit for this advertisement, if applicable, is: 100 For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/ 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: Yes, (3591) NTEU, (1449) - AFGE If you are serving, or have served in the last 5 years (from 07/17/2024) 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 Appointees 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. 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. 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 (07/17/2024); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process.