This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:Deputy Director, Regulatory and Quality Affairs

Department:Department Of Health And Human Services

Agency:Office of the Secretary of Health and Human Services

Job Announcement Number:HHS-ASPR-DE-13-895050

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.


$123,758.00 to $155,500.00 / Per Year


Thursday, May 30, 2013 to Friday, June 28, 2013




Full Time - Permanent




1 vacancy in the following location:
Washington DC, DC United StatesView Map


United States Citizens


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.

This position is located in the Department of Health and Human Services (HHS), Office of Assistant Secretary for Preparedness and Response (ASPR),Office of the Biomedical Advanced Research & Development Authority (BARDA), in Washington, DC.

This vacancy is also being announced concurrently with vacancy announcement HHS-ASPR-MP-13-895060 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. 

Additional selections may be made from this announcement.


  • U.S. Citizenship is required.
  • Must be able to obtain and maintain a Top Secret/CSI security clearance.
  • 20% to 30% domestic and international travel required.


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Incumbent will serve as a senior technical authority on overall operations for the Regulatory and Quality Affairs Division.  Assists in the management and strategic planning for the Division and its three branches.  Ensures products under contract comply with appropriate regulations.  Advises on all aspects of regulatory product development to include: the preparation of regulatory documents for submission to the Federal Drug Administration (FDA), planning and monitoring of regulatory issues related to pre-clinical and clinical programs, quality audits, FDA inspections, and product labels and labeling.  Provide input as required on project planning, requirements writing, project management and risk assessment on high-priority medical countermeasure activities. Leads and develop regulatory and quality standards, objectives, and procedures concerning crosscutting issues including those pertaining to scientific research and coordination of these activities.  Advises on the need, procedures and implications of medical countermeasure development, acquisition and response initiatives.  Formulates, coordinates and publishes regulatory and quality guidance to resolve problem issues, expedite actions, implement new initiatives, improve processes and facilitate accomplishments of program objectives. 





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Basic Qualification Requirements for a Supervisory Regulatory Specialist, GS-401:

Have at least a bachelor's degree with a major in the biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the work of the position from an accredited college or university.


Have a combination of education and experience-Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education. 


Additional Qualification Requirements for a Supervisory Regulatory Specialist, GS-401-15:

Have one year of specialized experience, equivalent to the GS-14 grade level in the Federal service, managing and directing the coordination, monitoring and reviewing of broad/complex regulatory and quality affairs operations; implementing emergency preparedness and response activities; advising scientist and manufactures on regulatory requirements, external quality systems and on changes to systems and on storage, labeling, and packaging requirements; and managing human resources, financial and budgetary requirements, and administrative and operational matters; experience in the development and acquisition life cycle as it relates to regulated biologics, pharmaceuticals, and device products.

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:

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 is required.

6. One-year probationary period may be required.

7. Bargaining Unit Position: No

8. Drug Screening Required: No 

9. Recruitment Bonus may be authorized:  Yes

10. Domestic and International travel is required 20%-30% of the time.

11. Relocation incentive may be authorized: Yes

12. Student Loan repayment may be authorized: Yes

13. Annual Leave credit may be authorized: Yes


Once the application process is complete, a review of resume 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 resume and or supporting documentation, a determination is made that you have inflated your qualifications and or experience, you may lose consideration for this position.  Please follow all instructions carefully. Errors or omissions may affect your eligibility.  Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of three categories: Best Qualified, Well Qualified or Qualified.


The Category Rating Process does not add veterans’ preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).  Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):



1.  Knowledge of vaccination regulations to ensure compliance of vaccines and therapeutic acquisitions.

2.  Ability to provide day to day operational support to accomplish the division's values and missions.

3.  Ability to manage the Division's workload effectively and efficiently.

4.  Skill in oral communication.

5.  Skill in written communication.

6. Knowledge of the regulations pertaining to biologics, drugs and medical device products.

7. Ability to advise key personnel on regulatory compliance for the development, manufacture and use of therapeutics and vaccines.

8. Knowledge of administrative laws, advanced principles and policies, regulations and precedents as they relate to scientific, technical, medical, public health and regulatory issues.

9. Ability to analyze, evaluate, and resolve any regulatory/quality development issues that could impact the response to Public Health emergencies.



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


If you are a veteran with preference eligibility and you are claiming 5-points veterans' preference, you must submit a copy of your DD-214 or other proof of eligibility. If you are claiming 10-point veterans' preference, you must also submit an SF-15, "Application for 10-Point Veterans' Preference" plus the proof required by that form. For more information on veterans’ preference see

Males born after December 31, 1959 must be registered or exempt from Selective Service (see

For information on "People with Disabilities" please visit

Interagency Career Transition Assistance Program (ICTAP):  For information on how to apply as an ICTAP eligible see  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.


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To begin the process, click the Apply Online button to create an account or log in to your existing USAJOBS account. Follow the prompts to complete the assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.


Note: To return to a previously Saved or Incomplete application you may use the following link:


To fax supporting documents you are unable to upload, complete this cover page using the following Vacancy ID 895050.  Fax your documents to 1-478-757-3144.


If you cannot apply online:

  1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
  2. Print this 1203FX form to provide your response to the assessment questionnaire and
  3. Fax the completed 1203FX form along with any supporting documents to 1-478-757-3144. Your 1203FX will serve as a cover page for your fax transmission.This agency provides reasonable accommodation to applicants with disabilities.
  4. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Rockville Center HelpDesk Telephone (888)-478-4340; TTY/TDD:  Rockville/Bethesda Use (800) 877-8339; Baltimore Use (410) 786-0727, email  The decision on granting reasonable accommodation will be made on a case-by-case basis.

The following documents are required and must be received by the closing date of this announcement:

1. Your Resume'
2. A complete Assessment Questionnaire
3. Other supporting documents:
    - Veterans Preference Documentation, if applicable
    - College transcript

For Resume' and Application Tips visit:


To apply for this position, you must provide a complete Application Package which includes:


1. Your Résumé

2. A complete Assessment Questionnaire

3. Other supporting documents:

         - Veterans Preference Documentation, if applicable
              - College Transcripts

Note: You may submit an unofficial transcript or a list of college courses completed indicating course titles, credit hours, and grades received. An official transcript from an accredited educational institution is required if you are selected for the position.

The complete Application Package must be submitted by 11:59 PM (EST) on Friday, June 28, 2013.



Fatima A. Miller
Phone: (202)205-5144
Agency Information:
200 Independence Ave SW
HHH Building
Suite 801
Washington, DC


Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement.

You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed (generally 4-6 weeks).

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