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This Position Is No Longer Available

Job Title:  Deputy Associate Commissioner for Regulatory Affairs
Department:  Department Of Health And Human Services
Agency:  Food and Drug Administration
Job Announcement Number:  HHS-ES-2013-FDA-855813

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

The contents of the announcement can still be viewed.
$119,554.00 to $179,700.00 / Per Year
Tuesday, May 14, 2013 to Friday, June 28, 2013
Full Time - Senior Executive Service (SES)
1 vacancy in the following location:
Silver Spring, MD United StatesView Map
All groups of qualified individuals


Become a part of the Department that touches the lives of every American!  At the Department of Health and Human Services you can give back to your community, state, and country by making a difference in the lives of Americans everywhere.  Join HHS and help to make our world healthier, safer and better for all Americans.


This position is in the Senior Executive Service (SES), a small elite group of senior government leaders who possess a diverse portfolio of experience and the strong skills required to lead across organizations.  This dedicated corps of executives is charged with providing strategic leadership and upholding a commitment to public service that transcends loyalty to a specific agency mission or individual profession.  As an SES member you will influence the direction of innovation and transformation of the federal government and lead the next generation of public servants.  


This position is located in the Office of Regulatory Affairs (ORA), Office of Global Regulatory Operations and Policy (OGROP), within the Food and Drug Administration (FDA) in Silver Spring, Maryland.


The Office of Regulatory Affairs (ORA) is the lead office for all field activities at the FDA.  Regulating more than 135, 000 business establishments that annually produce, warehouse, import and transport $1 trillion worth of consumer goods, ORA protects consumers by maximizing compliance of FDA regulated products and minimizing risk associated with these products.  More than 4,000 ORA personnel in more than 200 locations work every day to minimize public health risk.


Exceptional recruiting difficulty may result in payment of recruitment or relocation bonus.


This position is also advertised under Job Announcement Number HHS-ES-2013-FDA-, series 301.


  • U.S. Citizenship is required.
  • Must be able to obtain and maintain a Top Secret Clearance.
  • Must complete 1 year SES probationary period, if not previously completed.
  • Application package must be received by closing date of the announcement.


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The incumbent serves as the Deputy Associate Commissioner for Regulatory Affairs (Deputy ACRA) and principal advisor to the Associate Commissioner for Regulatory  Affairs on the full range of ORA’s  activities including enforcement (regulatory and criminal), implementation of new laws and regulations, and overall strategic planning and prioritization. In this capacity, the incumbent shares fully the responsibility for planning, coordinating, directing and evaluating activities of the ORA. This includes providing executive leadership and managerial direction, through subordinate supervisors, to the Office of Resource Management (ORM); Office of Criminal Investigations; and the Office of Operations (OO). The Deputy ACRA directly supervises the Office of Communications and Quality Program Management (OCQPM), Office of Policy and Risk Management (OPRM), Office of Partnerships (OP), along with the IT, External Relations and Executive Secretariat Staffs in the Immediate Office of the ACRA.


In conjunction with the Associate Commissioner for Regulatory Affairs (ACRA), the incumbent manages and directs over 4,000 employees engaged in regulatory, enforcement, compliance activities and scientific programs which lead to greater public health protection. The incumbent is responsible for providing long range strategic direction for ORA policies and programs including the implementation of the Food Safety Modernization Act and the new Generic Drug User Fees Act. This includes the delegated authority to, and accountability for, making managerial and technical decisions required for successful program execution, administration and management.

As the Deputy Associate Commissioner for Regulatory Affairs, the incumbent provides executive and technical guidance for Agency programs; reviews and evaluates project proposals and plans submitted by ORA Offices/Regions in terms of soundness of scientific/technical reasoning, sufficiency of project proposal, relative priorities, availability of resources, and anticipated results.

The Deputy Associate Commissioner for Regulatory Affairs is the key official participating with the ACRA in carrying out the full range of responsibilities and acts with full authority over the total work of ORA during the ACRA's absence or unavailability.


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Specialized Experience Requirement

To be qualified for this position, you must provide evidence of experience in a managerial capacity. Typically, experience of this nature is gained at or above the GS-15 grade level in the Federal service, or its equivalent with state or local government, the private sector, or nongovernmental organizations.

Senior Executive Service Requirements

Current or former career SES employees are not required to address the Executive Core Qualifications (ECQs), but must address the Mandatory Technical Qualifications.  Unless you are currently serving under a career SES appointment, are eligible for reinstatement into the SES, or have successfully completed a SES Candidate Development Program approved by OPM, you must submit a narrative statement covering each of the Executive Core Qualifications in order to receive consideration for the position.

Public Health Service Commissioned Corps Officers interested in applying for this position to serve in the SES must resign their commission if selected.  If you are applying under this option, you must address both the Mandatory Technical Qualifications and Executive Core Qualifications in this announcement.  Public Health Service Commissioned Corps Officers interested in performing the duties of the position within the Commissioned Corps must address the Mandatory Technical Qualifications but are not required to address the Executive Core Qualifications.

Additional information on the proper preparation of ECQs is available by going to the Office of Personnel Management's web site at  Applicants are encouraged to follow the Challenge, Context, Action, and Result model outlined in the guide.

When responding to the Executive Core Qualifications, you must clearly show that you possess the experience, knowledge, skills and ability to perform the duties of this position by submitting narrative responses in which you detail your experience in each Executive Core Qualification.

Your examples should be clear and emphasize your level of responsibilities, scope and complexity of programs managed, program accomplishments with results of your actions, policy initiatives and level of contacts.  In addition, your responses should highlight your experience, training, and achievements in conjunction with the resume that you provide.  You should limit your narrative to two pages per each ECQ.

Mandatory Technical Qualifications

In addition to specialized experience, applicants must possess the following technical qualifications that represent the knowledge, skills, and abilities essential to perform the duties and responsibilities of the position:

1.  Senior level experience as a leader in a complex organization managing, planning, directing, and evaluating multidisciplinary activities of significant scope and effect.

2.  Demonstrated ability to build strong working relationships among people and organizations with diverse interests and/or opinions, such as industry, professional, public health or consumer organizations, media, other federal, state, or local agencies, foreign governments and Members of Congress.  

3.  Experience advising senior officials and implementing organizational policy.

Desirable Qualifications

It is desired that you have:

1.  Training, professional development, and outside professional activities that provide evidence of initiative, resourcefulness and potential for effective job performance at a senior level and honors, awards, or other recognition for performance or contributions related to the position.

2.  An advanced degree such as Juris Doctorate, Doctor of Philosophy, Medical Doctor, Masters in Business Administration or a Masters in Public Health degree. 

Executive Core Qualifications (ECQ)

Fundamental Competencies:  The following competencies are the foundation for success in each of the ECQs.  Interpersonal Skills; Oral Communication; Integrity/Honesty; Written Communication; Continual Learning; and Public Service Motivation.  These Fundamental Competencies are cross-cutting and should be addressed over the course of your ECQ narratives.

1.  Leading Change:  This core qualification involves the ability to bring about strategic change, both within and outside the organization, to meet organizational goals.  Inherent to this ECQ is the ability to establish an organizational vision and to implement it in a continuously changing environment. (Competencies:  creativity and innovation, external awareness, flexibility, resilience, strategic thinking, vision)

2.  Leading People:  This core qualification involves the ability to lead people toward meeting the organization's vision, mission, and goals.  Inherent to this ECQ is the ability to provide an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork, and supports constructive resolution of conflicts. (Competencies:  conflict management, leveraging diversity, developing others, team building)

3.  Results Driven:  This core qualification involves the ability to meet organizational goals and customer expectations.  Inherent to this ECQ is the ability to make decisions that produce high quality results by applying technical knowledge, analyzing problems, and calculating risks.  (Competencies:  accountability, customer service, decisiveness, entrepreneurship, problem solving, technical credibility)

4.  Business Acumen:  This core qualification involves the ability to manage human, financial, and information resources strategically.  (Competencies:  financial management, human capital management, technology management)

5.  Building Coalitions:  This core qualification involves the ability to build coalitions internally and with other Federal agencies, State and local governments, nonprofit and private sector organizations, foreign governments, or international organizations to achieve common goals.  (Competencies:  partnering, political savvy, influencing/negotiating)


Education Requirement

Degree that included at least 30 semester hours in one or a combination of the following:

biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly to consumer safety officer work.  The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.


Combination of education and experience -- courses consisting of at least 30 semester hours in the fields of study described in above, plus appropriate experience or additional education.

Other Requirements

The Ethics in Government Act, PL 95-521 requires the applicant selected for this position to submit a financial disclosure statement, SF-278, prior to assuming the SES position, annually, and upon termination of employment.  Status applicants must submit a copy of their most recent SF-50, Notification of Personnel Action, which verifies status.

All applicants will be considered without regard to race, color, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, disabling condition, membership in an employee organization, or any other non-merit factors.

All initial appointments to an SES position are contingent on approval from OPM's Qualifications Review Board unless the selectee has successfully participated in an OPM approved SES Candidate Development Program.

In accordance with Federal and Agency Travel regulations, the payment of travel and relocation expenses may be reimbursed for travel, transportation and relocation expenses associated with reporting for duty to this position.

As a condition of employment, all male applicants born after December 31, 1959, must have registered for the selective service.  If selected for this position, the applicant must sign a statement certifying his registration, or the applicant must demonstrate exempt status under the Selective Service Law.

Only experience obtained by the closing date of this announcement will be considered.


Your resume and narrative responses to the technical qualifications and the five Executive Core Qualifications are an integral part of the process for determining your basic and specialized qualifications for the position.  Responses that are not supported by your resume will eliminate you from consideration.  Your application will be evaluated in the following manner:

1.  Application packages will be reviewed for completeness (incomplete or late packages will not receive further consideration).

2.  Basic qualifications review.  Your resume and questionnaire will be reviewed to ensure that you meet the Specialized Experience Requirement.  (If you do not meet this requirement, you will not receive further consideration).

3.  Review of your supplemental qualifications document to determine your rating.


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


Veteran's Preference does not apply to the SES.

Drug Free Workplace

The incumbent of this position will be subject to testing for drug usage in accordance with the HHS plan for a Drug Free Workplace.

Financial Disclosure: All employees of the Federal Government are subject to the conflict of interest statues and regulations, including the Standards of Ethical Conduct, that govern activities with outside organizations and reporting financial holdings.  This position will require the incumbent to complete a public financial disclosure report prior to the effective date of appointment.



This position within FDA is subject to strict restrictions on financial holdings (FDA regulated financial holdings).  Applicants are advised to seek additional information from the Ethics Staff prior to accepting such a position.  Please refer to the following website:


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To apply for this position, you must provide a complete Application Package, which includes ALL of the documents listed in the Required Documents section of this vacancy announcement.  Any documents submitted that are not listed in the Required Documents section of this announcement will not be considered or forwarded to the rating panel or selecting official.

Application packages for this vacancy must be received on-line via the USA Staffing web site by 11:59 PM (EST) on Friday, June 28, 2013.

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.  You may preview the assessment questionnaire by clicking here:  View Occupational 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 Identification Number:  855813.  Fax your documents to 1-478-757-3144.

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful.

If applying online poses a hardship to you, please contact the Employee Resource & Information Center (ERIC) HelpDesk Telephone (866)807-3742, TTY/TTD (800)877-8339; or email  You must contact the ERIC HelpDesk prior to the closing date of this announcement to receive assistance.  The decision on granting reasonable accommodation will be made on a case-by-case basis.  Hours of operation:  Monday through Friday 7:00AM to 6:00PM EST.


1. Resume - Ensure that your resume contains your full name, address, phone number, and social security number.  When uploading your resume, choose the supporting document type called "Resume;"

2. Completion of online Questionnaire; including responses to Mandatory Technical Qualifications (MTQs) and Executive Core Qualifications (ECQs); 

3. SF-50, Notification of Personnel Action, showing your current or former civil service status, if applicable.

4.  Proof of OPM Qualifications Review Board certification (OPM-approved SES Candidate Development Program graduates), if applicable.

5.  Transcript.

If you do not submit the documents above by the closing date of the announcement, the system will consider your application incomplete, and you will receive no further consideration.  Any documents submitted that are not listed above will not be considered or forwarded to the rating panel or selecting official.


Kisha Hightower
Phone: (240)402-4350
Agency Information:
HHS FDA Center Executive Resources
10903 New Hampshire Avenue
Silver Spring, MD


We expect to make a selection within 90 days of the closing date of this announcement.  You will be notified of the outcome by e-mail using the e-mail address on file in the Application Manager system, or by postal mail if no email address was provided by you during the application process.

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