Regulatory Scientific Reviewer (Regulatory Health Project Manager)

Full Job Description

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624.

The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

This position is being recruited based on the Title 21 Pay Table 1, Band Y (GS-09 equivalent ) In order to qualify for the Regulatory Scientific Reviewer (Regulatory Health Project Manager) position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/20/2026: Basic Qualification Requirements: You must have a 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.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

AND IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. 1.

Have a bachelor's degree and also have 1 year of comparable experience participating in compliance-related activities and supports efforts to ensure regulated products meet safety standards. 2.

Have a master's degree and also have 0 years of comparable experience participating in compliance-related activities and supports efforts to ensure regulated products meet safety standards. 3.

Have a Doctorate and/or J.D.

degree and also have 0 years of comparable experience participating in compliance-related activities and supports efforts to ensure regulated products meet safety standards. Major Duties:

The regulatory scientific reviewer serves as a developing professional in an early career position who conducts basic regulatory reviews and scientific evaluations under close supervision and guidance within their area of training.

The reviewer is building foundational expertise in regulatory processes and applies fundamental scientific principles and regulatory knowledge to support the assessment of submissions and data while developing competency in routine regulatory activities.

The reviewer applies fundamental scientific principles and regulatory knowledge to support the assessment of submissions and data.

The scientist works as part of review teams and contributes to regulatory activities under supervision.

The reviewer assists more experienced staff in the evaluation of regulatory submissions by reviewing well-defined, designated portions of manufacturing information, quality data, and labeling materials following established procedures and methodologies.

The scientist supports and learns from multidisciplinary review efforts and contributes to the assessment of product compliance with FDA requirements under the direction of senior reviewers.

The scientist supports multidisciplinary review efforts and contributes to the assessment of product compliance with FDA requirements.

Under supervision, participates in compliance-related activities and supports efforts to ensure regulated products meet safety standards.

The scientist is in the process of developing technical expertise in regulatory processes within their specialty area.

This includes actively learning review methodologies, participating in training on scientific and regulatory principles, gaining exposure to routine regulatory activities, and building knowledge of typical varieties of work performed in the specialty area.

The reviewer works closely with senior staff to support the preparation of regulatory documents and engages in structured professional development activities aimed at progressing toward independent practice.

This includes learning review methodologies, participating in training on scientific and regulatory principles, and contributing to routine regulatory activities.

The reviewer supports the preparation of regulatory documents and participates in professional development activities.