Regulatory Health Project Manager

About the role

This position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Science, Division of Regulatory Project Management. Duty Station and Telework Notice: This is not a fully remote position.

The selectee must adhere to the FDA Telework Policy, which requires regular in-person reporting to a designated FDA facility as determined by agency policy.

What you will do

• Serve as a Regulatory Health Project Manager and Technical Project Lead (TPL) Coordinator for a multidisciplinary review team responsible for the assessment of pre-market applications of proposed new tobacco products.
• Develop the Technical Project Lead Review (TPLR) report and provides technical support, clarifications, edits of the rationale and justification of the marketing order for the products under review.
• Provide authoritative recommendations and guidance to other Center review organizations, review scientists, and the regulated industry.
• Serve as a regulatory health, scientific authority in representing the Center at local, state, and national meetings on matters concerning regulated products.

Education

TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements.

You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format.

Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

FOREIGN EDUCATION Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.

Note: Some positions require the completion of specific courses or a specified number of credit hours.

Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the ***

How you will be evaluated

You must meet the requirements of the job by 11:59 (Eastern Standard Time) of the closing date: 11/06/2026 Your eligibility for consideration and qualifications for the position (as listed in this vacancy announcement above) will be evaluated based on your application materials (e.g., resume, supporting documents) and your score from the required assessment(s).

The application review process will be conducted in multiple stages: Eligibility Consideration: Once the application process is complete, the Human Resources Office will review your application and supporting documentation to determine it is complete, meets the two (2) page resume limit and meets the eligibility requirements for this vacancy.

Minimum Qualifications: Then, the Human Resources Office will review your resume and supporting documentation to determine whether you meet the minimum job requirements and qualifications.

Assessment and Rating Process: This vacancy will use the following assessment(s): STRUCTURED RESUME REVIEW Next, the Human Resources Office and/or Subject Matter Experts (SMEs) will review your technical qualifications based on the extent and quality of your experience, education (if applicable to the job), and training described in your resume, questionnaire, and assessment documentation as related to the duties and competencies of this position.

You will be assessed on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these competencies.

Technical Competence Technical Credibility Writing Oral Communication This assessment and rating process will determine your quality category for referral.

Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration or your score may be adjusted to more accurately reflect your skills and abilities. All qualified Non-Competitive applicants and the best-qualified applicants will be referred to the hiring manager for consideration.

Career Transition Assistance Programs: Employees who have been involuntarily separated from a Federal service position within the competitive service or whose positions have been deemed surplus or no longer needed.

To receive selection priority, you must: 1) meet CTAP or ICTAP eligibility criteria; 2) be rated well-qualified for the position (obtain a score of 85 or higher on assessments); and 3) submit the appropriate documentation to support your CTAP or ICTAP eligibility.

Referral Consideration: If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview, review of requested work samples, etc. Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Documents you must provide

• At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed.
• A CV (curriculum vitae) may not contain enough information to meet these resume requirements.
• USAJobs - What to Include USAJobs - Page Limit Your two (2) page RESUME showing all relevant work experience (paid and unpaid) including: duties performed; full name and address of the each employer; start and end dates (month/day/year); work schedule (part-time, full-time, number of hours if intermittent); salary; and any completed education and training (program title, subject area, number of hours completed, and completion date).
• Transcripts and Professional Licensure: If the position has an education or licensure requirement or you are qualifying based on education, unofficial transcripts or a list of courses and a copy of your professional license must be provided.
• See the Qualifications and Education Requirements section of this announcement.
• Current and Former Federal Employees: To verify your eligibility and status, you must submit your most recent SF-50 showing you are/were in the competitive service and the highest grade or promotion potential held.
• The SF-50 must also show the following: Full position title; Pay Plan, Series, Grade, & Step; Position Occupied; Tenure code; and Service Computation Date (SCD).
• If you are applying for a higher grade, the SF-50 provided must also demonstrate you meet time-in-grade.
• NOTE: Annual pay adjustment and award SF-50s normally do not show time-in-grade is met.
• Multiple SF-50s may need to be submitted to show all the required information.
• Learn more on the USAJOBS SF-50 Help Page.
• Current Federal Employees: To receive due weight for performance appraisals and incentives, provide a copy of your most recent performance appraisal (dated within 18 months of application) showing rating received.
• Incentives received and accomplishments may be listed in your resume instead of on a separate document.
• CTAP: If you are a surplus or displaced HHS employee, please submit supporting documentation (e.g., a Certification of Expected Separation, separation notice, RIF separation notice, notice of proposed removal, SF-50 for RIF separation, etc.) and your most recent performance appraisal.
• To be selected under CTAP, you must be found well-qualified for this position and have a current performance appraisal rating of at least "Fully Successful".
• See the How You Will Be Evaluated section for the agency's definition of well-qualified.
• Learn more on the USAJOBS Career Transition Assistance Site Schedule A (individuals with disabilities): Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may apply for appointment through the Schedule A hiring authority.
• Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.

What to expect next

Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 11/06/2026), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position.

If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible, or your score may be adjusted to more accurately reflect your skills and abilities.

HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners.

In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.

Once your application is submitted, you will receive an email notice confirming that your submission was successful. You will receive additional application status updates by email and through USAJOBS as the process unfolds. How to check your application status and understand what each status means.

Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.

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Additional information

In accordance with Executive Order 14170, applicants are encouraged to respond to the four short, free-response, essay questions in the questionnaire. Answers to these questions are optional and will not be scored or rated. Your answers will be reviewed by the hiring manager and agency leadership if you are referred for selection consideration.

You will be asked to certify that your responses are written in your own words and that you did not use a consultant or artificial intelligence (AI) tool (such as ChatGPT or Copilot).

Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

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: No Drug testing: No License: No Mobility agreement: No Immunization: No Bargaining Unit: No If you are serving, or have served in the last 5 years (from 11/06/2026) 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: *** Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring.

To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring.

All requirements must be met by the closing date of this announcement (11/06/2026); only education and experience gained by this date will be considered.

You must continue to meet all requirements throughout the hiring process.