Skip to main content
U.S. flag
Back to results

Director, Office of Regulations

Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
This job announcement has closed

Summary

The Center for Tobacco Products (CTP) provides an innovative work environment for its employees. As a Senior Leader, you are expected to possess team, management, and leadership skills needed to lead a dynamic and growing organization. The management skills will enhance overall performance and productivity of the staff while creating a vibrant work culture. To learn more about the CTP, please visit the following link: https://www.fda.gov/TobaccoProducts/AboutCTP/default.htm.

Overview

Help
Reviewing applications
Open & closing dates
07/06/2020 to 08/06/2020
Salary
$131,239 to - $197,300 per year
Pay scale & grade
ES 00
Location
1 vacancy in the following location:
Silver Spring, MD
Telework eligible
Yes—as determined by the agency policy.
Travel Required
Occasional travel - You may be expected to travel for this position.
Relocation expenses reimbursed
No
Appointment type
Permanent
Work schedule
Full-Time
Service
Senior Executive
Promotion potential
00
Job family (Series)
Supervisory status
Yes
Security clearance
Secret
Drug test
No
Position sensitivity and risk
Noncritical-Sensitive (NCS)/Moderate Risk
Trust determination process
Announcement number
FDA-CTP-ES-20-10830861
Control number
572721200

This job is open to

Help

Federal employees - Competitive service

Current federal employees whose agencies follow the U.S. Office of Personnel Management's hiring rules and pay scales.

Federal employees - Excepted service

Current federal employees whose agencies have their own hiring rules, pay scales and evaluation criteria.

Senior executives

Individuals looking for an executive-level job and who meet the five Executive Core Qualifications (ECQs).

Clarification from the agency

Current Federal employees, SES reinstatement eligibles or Candidate Development Program Graduates.

Duties

Help
  • Performs work and leadership in the development of CTP's regulatory responsibilities related to the planning, execution, and coordination of nationwide programs and policies regarding the regulation of tobacco products intended for human use.
  • Advises the Center Director and other FDA officials on legal, administrative, and regulatory requirements and policies concerning FDA's regulatory responsibilities relating to the Family Smoking Prevention and Tobacco Control Act.
  • Leads, participates in, and contributes to, as appropriate, top level Center, Agency, and Department discussions, meetings, and conferences on broad regulatory matters and issues.
  • Monitors, coordinates, and advises the Center Director on new or revised policy related to the regulatory responsibilities of the CTP.
  • Advises the Center Director, senior FDA officials, and others on regulatory and policymaking activities that affect Center-wide programs, projects, and initiatives, or have an impact on the development and execution of long-range program goals.
  • Develops, prepares, and presents authoritative memoranda, briefings, position papers, and other materials concerning substantive questions, issues, findings, conclusions, and proposed solutions and suggested courses of action
  • Maintains knowledge and awareness of the Center Director's strategic priorities, and provides leadership developing and implementing regulations and guidance documents, developing adequate administrative records to support the Center's activities.
  • Exercises leadership, analytical skills, and judgment in discussions, meetings, and conferences with top level Center, Agency, and Departmental officials, industry representatives, program directors, subject matter experts and others.
  • Secures and provides information concerning ongoing or proposed activities that may affect the conduct, coordination, execution, or administration of Center policies and programs; discusses questions and problems.
  • Participates in providing executive leadership to the Center in formulating, developing, and shaping CTP's policies, programs, projects, and legislative initiatives or recommendations, including its short- and long-range goals.
  • Manages the process of obtaining the appropriate clearances of the Center's regulations and guidance documents from the Agency, the Department, and OMB.
  • Serves as the Director, Office of Regulations overseeing staff and work of the Office.

Requirements

Help

Conditions of employment

  • U.S. Citizenship is required for federal employment.
  • Background and/or Security Investigation is required.
  • Must complete 1 year SES probationary period, if not previously completed.
  • Application package must be received by closing date of this Announcement.
  • Ethics pre-clearance is required.

Qualifications

In order to qualify for Director, Office of Regulations, 0301, ES - 00, you must possess the following:

      • Specialized Experience Requirement
      • Basic Qualification Requirements
      • Technical Qualifications (TQs)
      • Executive Core Qualifications (ECQs)
Specialized Experience Requirement
To be qualified for this position, your résumé must reflect experience in a managerial capacity with responsibility for providing supervisory direction to a large and diverse organization responsible for promoting economy, efficiency, and effectiveness in the administration of programs and operations and preventing and detecting fraud and abuse in such programs and operations. This experience must be evidenced by sophisticated analytical skills, superior written and oral communication skills, good judgment, and experience in interacting with government and non-government officials. 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. At this level, you would have typically been responsible for planning, directing, and evaluating work that included managing and/or supervising other managers. You must demonstrate in your résumé, significant achievements, increasing levels of responsibility as a manager, and a solid record of successful professional performance.

Basic Qualifications Requirement
As a basic requirement for entry into the Senior Executive Service (SES), your résumé must show evidence of progressively responsible leadership experience that is indicative of senior executive level management capability, and that is directly related to the skills and abilities outlined under:

1) Technical Qualifications (TQs); and
2) Executive Core Qualifications (ECQs)

Technical Qualifications (TQs) -- Your résumé must show that you possess the following TQs:
1. Knowledge of the Federal, Food, Drug, and Cosmetic Act gained from experience related to the interpretation, application, explanation, or enforcement of its laws, rules and regulations.
2. Senior level experience in the federal regulatory process which included the development and evaluation of regulations, guidance documents, and policies for national and / or international programs.
3. Strong leadership and thorough knowledge and effective skills in administration and management with emphasis in a regulatory review or public health environment.
4. Strong oral and written communication skill s as evidenced by experience drafting guidance documents, notices of proposed rulemaking and final rulemaking and petition responses; and making oral presentations on complex regulatory issues or providing advice to senior officials and stakeholders.

Desirable Qualifications (DQs)-It is desired that you have (please show evidence in resume):
1. Law degree from an accredited university.

Executive Core Qualifications (ECQs) -- Your résumé must show that you possess the following ECQs:

1.Leading Change
2. Leading People
3. Results Driven
4. Business Acumen
5. Building Coalitions

Fundamental Competencies are the foundation for success in each of the ECQs and should be evident over the course of your résumé:

1. Interpersonal Skills
2. Oral Communication
3. Integrity/Honesty
4. Written Communication
5. Continual Learning; and
6. Public Service Motivation

It is STRONGLY recommended that you visit the following Office of Personnel Management (OPM) webpage for more information regarding the Fundamental Competencies and ECQs. https://www.opm.gov/policy-data-oversight/senior-executive-service/executive-core-qualifications/.

1. Leading Change: 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: 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: 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: The ability to manage human, financial, and information resources strategically. (Competencies: financial management, human capital management, technology management)

5. Building Coalitions: 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)

Additional information on the proper preparation of ECQs is available by going to the Office of Personnel Management's web site at http://www.opm.gov/ses/references/GuidetoSESQuals_2010.pdf. Applicants are encouraged to follow the Challenge, Context, Action, and Result model outlined in the guide.

The application process for this position is RESUME ONLY. You should address the TQs and ECQs within the context of a 5-page résumé. Any information submitted in excess of 5 pages WILL NOT be considered. We strongly encourage you to submit a résumé that is tailored specifically for this position to ensure it includes relevant examples of how you possess the technical qualifications and the five Executive Core Qualifications. Your résumé should emphasize your level of responsibilities, the scope and complexity of programs managed (e.g., budget, type/# of staff supervised) and program accomplishments, including the results of your actions.

If selected, you will be required to complete an ECQ package by drafting narratives for each of the ECQs for submission and certification by an OPM Qualifications Review Board (QRB) in order to be placed in this position. If you are currently serving in a career SES appointment, are eligible for reinstatement into the SES, or have successfully completed an SES Candidate Development Program approved by the Office of Personnel Management (OPM), you will not need to draft the ECQs.

Public Health Service Commissioned Corps Officers interested in applying for this position to serve in the SES must resign their commission if selected.

Education

There is no education requirement for this series.

Additional information

      • If you are serving, or have served in the last 5 years from the closing date of this announcement 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 Appointee FAQ - OPM
      • Probationary Period: Persons newly selected for career appointment to the SES must have their ECQs approved by the OPM Qualifications Review Board and will be required to serve a one-year probationary period.
      • Relocation/Moving Expenses: Will not be authorized.
      • A one-time Relocation or Recruitment Incentive may be offered.
      • Mobility: Individuals selected for SES positions may be subject to reassignment across geographic, organizational, and functional lines.
      • Direct Deposit: All Federal employees are required to have Federal salary payments made by electronic direct deposit to a financial institution of their choosing.
      • Selective Service: As a condition of employment, all male applicants born after 12/31/1959, 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.
      • Veterans' Preference: Does not apply to the SES.
      • Reasonable Accommodation: This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Center HelpDesk (888) 478-4340; TTY/TDD: (866) 539-4484; or by email quickquestions@fda.hhs.gov. The decision on granting reasonable accommodation will be made on a case-by-case basis.
      • Equal Employment Opportunity: The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
      • 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.
Benefits for federal employees:
https://www.usajobs.gov/Help/working-in-government/benefits/


How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm ET on 08/06/2020).

Your résumé and responses to the Assessment Questionnaire are an integral part of the process for determining your basic and specialized qualifications for the position. Responses that are not supported by your résumé 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 résumé 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. If it is determined that you meet the basic qualifications for the position, your application package will be further evaluated by a rating and ranking panel, and highly qualified candidates may be invited to participate in a structured interview, submit writing samples, and undergo reference checks. Top candidates may be required to submit further written documentation of qualifications.

4. The HHS FDA Executive Resources Board will review results and make recommendations on final selections to the appointing authority.

All information concerning qualifications is subject to investigation. You should expect that we will verify performance, suitability, security information and take that information into account in making employment offers. False representation may be grounds for non-consideration, non-selection, and/or appropriate disciplinary action. 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. An individual's initial SES career appointment becomes final only after the individual successfully completes a 1-year probationary period. For additional information concerning the SES visit http://www.usajobs.gov/SeniorExecutives.

Your session is about to expire!

Your USAJOBS session will expire due to inactivity in 8 minutes. Any unsaved data will be lost if you allow the session to expire. Click the button below to continue your session.