Regulatory Health Project Manager

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 hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

You must submit supporting documentation to verify your eligibility to apply for this vacancy. For internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question. See the Required Documents section for full details...

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.