Sunday, March 16, 2014

Regulatory Counsel (GS-0301-14) - FDA (Silver Springs, MD)

See original job posting here.

Job Title:Regulatory Counsel
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Job Announcement Number:FDA-CDER-14-DE-1048502BB


$106,263.00 to $138,136.00 / Per Year


Thursday, February 27, 2014 to Tuesday, March 18, 2014




Full Time - Permanent


Many vacancies in the following location:
Silver Spring, MD View Map


United States Citizens


Not Applicable




Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
As a Regulatory Counsel in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigation (OSI) or Office of Unapproved Drugs and Labeling Compliance (OUDLC), you will serve as a legal/regulatory expert resolving a broad range of legal/regulatory issues concerning the application of FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government.

This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-14-MP-1048514BB under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

This job opportunity announcement may be used FDA-wide to fill additional vacancies within the same geographical location.


  • Not Required


  • No


  • U.S Citizenship
  • Suitability for Federal employment determined by background investigation
  • May be required to serve a one-year probationary period


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  • Develops and revises regulations and guidance, advising on compliance with FDA's Good Guidance Practice regulations and other legal/regulatory issues.
  • Reviews and drafts policy proposals and decisions.
  • Performs legal/regulatory reviews of petitions raising issues with industry-wide effect.
  • Provides technical guidance on procedures and methods involved in implementing new programs, guidance, and regulations.
  • Informs management and staff on new or revised regulations, internal policies and procedures, and trends in the pharmaceutical and health care industry.
  • Ensures legal/regulatory sufficiency of action packages for regulatory enforcement actions.
  • Makes presentations at national and international conferences and professional meetings regarding applicable regulations and policies.


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GS-14: At least one year of specialized experience, equivalent to the GS-13 in the Federal service that included analyzing, evaluating, and developing statutes and regulations affecting technical regulatory and compliance programs for drugs; consulting management and staff on developing and implementing compliance policy and strategic enforcement initiatives for legal/regulatory matters under the Federal Food, Drug, and Cosmetic Act (FDCA), such as responding to and/or enforcing FDCA warning letters; and directing the legal/regulatory review of an organization's policies and practices.

Experience in applying the Food, Drug, and Cosmetic Act must be clearly reflected in your CV and/or resume.

All qualification requirements must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement.
Conditions of Employment:
1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.
2. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
4. All qualification requirements must be met by the closing date of the announcement.
5. Financial Disclosure statement may be required.
6. One-year probationary period may be required.
7. Travel, transportation, and relocation expenses paid: Maybe
8. Bargaining Unit Position: Yes
9. Drug Screening Required: No
10. Recruitment incentives may be authorized: Maybe
11. Student loan repayment incentive authorized: No
12. Annual leave for non-federal service authorized: Maybe


Once the job opportunity announcement closes, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.
If, after reviewing your résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, your score may be adjusted to more accurately reflect your skills and abilities Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Qualified candidates will be assigned to the following quality categories:
Best Qualified - Applicants who have experience that is almost identical to those required by the position.
Well Qualified - Applicants who have experience that is very similar to those required by the position.
Qualified - Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.
The category assignment is a measure of the degree in which your background matches the required competencies listed below for this position.
  • Technical Guidance in Regulatory Procedures
  • Regulatory Review
  • Written Communication
  • Oral Communication

  • Application of Veterans' Preference: Under Category Rating procedures, veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.
    To preview the assessment questionnaire, click the following link: View Assessment Questions


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    The Federal government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at


    Veterans' Preference: If you are a veteran claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement (including Character of Service) from your command if currently on active duty. If you are claiming 10-point veterans' preference, in addition to the DD-214, you must also submit a Standard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form. For more information on veterans' preference, go to

    Career Transition Program: This program applies to Federal workers whose positions have been deemed 'surplus' or no longer needed, or an employee has been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must be rated 'well-qualified.  Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position. For information on how to apply and hat documents to submit as a CTAP/ICTAP eligible, go to:
    Selective Service:  The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position.  For further information concerning Selective Service requirements, please visit


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    To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.
    The complete application package must be submitted by 11:59 PM (EST) on Tuesday, March 18, 2014 to receive consideration.
    * To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.
    * Click the Submit My Answers button to submit your application package.
    * 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 @ and click 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.
    To return to an incomplete application, log into your USAJOBS account @  and click Update Application in the vacancy announcement.  You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
    To complete a hard copy assessment questionnaire and submit it via fax: Do not complete the steps below if you have already applied online to the questionnaire for this position.
    1) Print the instructions and questionnaire by clicking View Occupational Questionnaire.
    2) Print the 1203FX form to record your responses to the questionnaire.
    3) Fax the completed 1203FX (all 6 pages but do not include a Cover Page for this document) to: 


    • Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.
    • Responses to the Assessment Questionnaire
    Other Supporting Documents: (Only submit if applicable to you.)
    • Veterans' Preference documentation (i.e. SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc. ) 
    • CTAP/ICTAP documentation
    If you are unable to upload supporting document(s) online, you can fax them by completing the following steps:
    1. Print out a Fax Cover Page @ and complete the required information. The Vacancy ID is 1048502
    2. Fax a Cover Page with each supporting document to 1-478-757-3144 by 11:59 PM (EST) on Tuesday, March 18, 2014 to receive consideration. Keep a copy of your fax confirmation in the event verification is needed.


    Mid-Atlantic Services Branch
    Phone: (757)441-6765
    Agency Information:
    1900 E St NW
    Washington, DC


    You will be notified of your status when the list of candidates has been referred to the hiring manager for employment consideration.