Regulatory Health Project Manager

Summary

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.

Duties

• 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.

Qualifications

The position of Regulatory Health Project Manager falls within the 0601 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 11/06/2026. BASIC QUALIFICATION REQUIREMENT - 0601 General Medical and Healthcare Series Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education(external link) at the time the degree was obtained. MINIMUM QUALIFICATION REQUIREMENTS GS-14: Applicant must have one (1) year of specialized experience equivalent to at least the GS-13 grade level in the Federal service, which includes assessing pre-market applications for proposed new regulated products; drafting scientific reviews for the appropriate application pathways (e.g., Premarket Product Applications, Substantial Equivalence, Exemption, or Modified Risk Product Applications); and providing advice related to regulated products. Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. The specialized experience must demonstrate one year of full-time work experience , or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above. PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment. NOTE: 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,https://secure.login.gov/ select 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. IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of ho…

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…