Technical/Research Regulatory Affairs Specialist/Subject Matter Expert for Food and Drug Administration (FDA)
ID: SS-AFRL-PZLEQ-2025-0014Type: Sources Sought
Overview

Buyer

DEPT OF DEFENSEDEPT OF THE AIR FORCEFA2396 USAF AFMC AFRL PZL AFRL PZLEWRIGHT PATTERSON AFB, OH, 45433-7541, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

SUPPORT- PROFESSIONAL: OTHER (R499)
Timeline
    Description

    The Department of Defense, specifically the Air Force Research Laboratory (AFRL), is seeking a part-time Technical/Research Regulatory Affairs Specialist/Subject Matter Expert to support Food and Drug Administration (FDA) regulatory affairs at Wright-Patterson Air Force Base in Ohio. The contractor will provide expertise in FDA compliance for human research activities, requiring a minimum of five years of experience in FDA regulatory requirements and clinical research protocol compliance. This role is crucial for ensuring adherence to regulations related to human subject research, with responsibilities including analyzing research proposals, assisting with FDA submissions, and developing regulatory training materials. Interested small businesses must submit their capability packages by May 2, 2025, at 5:00 PM Eastern Standard Time, to Gabrielle Ruiz at gabrielle.ruiz.1@us.af.mil, and include relevant company information and experience as outlined in the attached Performance Work Statement.

    Point(s) of Contact
    Files
    Title
    Posted
    The Air Force Research Laboratory (AFRL) is seeking a contractor to provide part-time regulatory affairs expertise focused on FDA compliance for human research activities. This role, specifically filled by a Technical Research Regulatory Affairs Specialist, requires at least 5 years of experience in FDA regulatory requirements, with a strong background in clinical research protocol compliance. Key responsibilities include analyzing research proposals, assisting with FDA submissions, developing regulatory training materials, and ensuring adherence to various regulations related to human subject research. Contractor performance metrics include ensuring qualified personnel availability, timely replacements, and maintaining a stable workforce with low turnover. The work is primarily remote, with a flexible schedule not to exceed 24 hours per week. Contractor personnel must complete security background checks and follow strict IT policies regarding data security and equipment use. All necessary equipment will be provided by the government, with specific requirements outlined for telework and training. The PWS emphasizes compliance with quality levels and methods for reporting performance. This initiative reflects the AFRL's commitment to advancing human performance research while adhering to regulatory standards.
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