Regulatory Counsel

Employer
USAJobs
Location
Silver Spring, Maryland
Posted
Oct 27, 2021
Closes
Nov 03, 2021
Function
Administrative
Hours
Full Time
Duties

  • Leads or serves as member of task forces and study groups convened to consider problems or direction in the area of regulatory policy.
  • Advise reviewers on the extent of regulatory authority in specific situations and provides guidance and/or training to regulatory specialists and other professionals on matters relating to his/her expertise.
  • Provides regulatory expertise in evaluating and developing responses to letters of reply {and inquiry) from the pharmaceutical industry which contain legal arguments.
  • Advise the Office/Division Director{s) on issues raised in litigation that may affect the activities of the Office/Division(s).
  • Makes presentations at conferences and professional meetings before the regulated industry and the medical/scientific/legal community on the applicable regulations and policies.


Requirements

Conditions of Employment

  • Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
  • 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.
  • Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
  • 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.
  • Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
  • 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.
  • You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
  • 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.
  • Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.


Qualifications

The position of Regulatory Counsel falls within the 0301 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 11/09/2021.

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.

SPECIALIZED EXPERIENCE REQUIREMENT: Minimum Qualification
In order to qualify for the position of Regulatory Counsel, GS-0301-14, you must have one year of specialized experience, equivalent to the GS-13 in the Federal service which include specialized experience in analyzing and evaluating regulatory activities, processes, policies, and issues; providing recommendations involving current and proposed regulations or policies; developing correspondence pertaining to regulatory and scientific issues, such as legal pleadings and briefs, and legal memoranda.

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.

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://my.usajobs.gov/Account/Login , 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-14 grade level

Additional information

ADDITIONAL CONDITIONS OF EMPLOYMENT:

We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.
  • Pre-employment physical required: No
  • Drug testing required: No
  • License required: No
  • Mobility agreement required: No
  • Immunization required: No
  • Bargaining Unit Position: Yes, 3591
  • If you are serving, or have served in the last 5 years (from 11/09/2021) 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
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 .

Vaccination Mandate :
  • In accordance with Executive Order 14043 , Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccination requirement.
Expanded/Maximum telework Posture :
Due to COVID-19, the agency is currently in a maximum telework posture. If selected, you may be expected to telework upon your appointment. As employees are permitted to return to the office, you may be required to report to the duty station listed on this announcement, even if your home/temporary telework site is located outside the local commuting area. Your position may be eligible for workplace flexibilities which may include remote work or telework options, and/or flexible work scheduling. These flexibilities may be requested in accordance with the HHS Workplace Flexibilities policy.

All requirements must be met by the closing date of this announcement (11/09/2021); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process.
Additional selections may be made within the same geographical area FDA-wide.

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