Technical/Research Regulatory Affairs Specialist/Subject Matter Expert for Food and Drug Administration (FDA)
Closed Pre-Solicitation Posted
- Solicitation number
- SS-AFRL-PZLEQ-2025-0014
- Agency
-
Air Force Research Laboratory
Air Force Materiel Command, Department of Defense
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- R499 Support- Professional: Other
- Place of performance
- Wright Patterson AFB, Ohio 45433, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Air Force Research Laboratory (AFRL) at Wright-Patterson Air Force Base is seeking a part-time (.4 FTE) Technical/Research Regulatory Affairs Specialist/Subject Matter Expert to support FDA regulatory affairs. This Sources Sought (SS)/Request for Information (RFI) is targeting small businesses to provide a primarily telework contractor who will conduct expert technical FDA regulatory reviews of research proposals, analyze research protocols, and provide compliance guidance to researchers. Key qualifications for the contractor include 5 years of FDA research regulatory experience, 3 years of clinical research protocol compliance administration, a bachelor's degree in a technical field, and professional certification. Interested companies must submit capability packages by May 2, 2025, at 5:00 pm Eastern Standard Time via email to Gabrielle Ruiz, addressing specific questions about company capabilities, small business status, experience, and potential risks. Evaluation criteria will focus on personnel availability, workforce stability, customer service, security compliance, and timely deliverable submissions.
The opportunity is not set aside for any specific small business designation, though small businesses are encouraged to respond. The contract requires U.S. citizen contractors who can complete a Tier 1 background check and work a flexible schedule not exceeding 24 hours per week, typically between 0730-1630 Monday-Friday. While specific award value is not disclosed, the position is classified under NAICS category 541714 for Research and Development in Biotechnology and PSC category R499 for Professional Support Services. The contractor will be expected to interface with various Air Force and FDA offices, develop training materials, and provide expert regulatory guidance while adhering to specific IT security and operations security protocols. The telework nature of the position and the specialized technical expertise required suggest this will be a carefully selected, high-value professional services contract.
Notice text
The Air Force Research Laboratory (AFRL) at Wright-Patterson Air Force Base has a requirement to purchase a part time (.4 FTE), primarily telework, Technical/Research Regulatory Affairs Specialist/Subject Matter Expert for Food and Drug Administration (FDA) regulatory affairs at Wright-Patterson Air Force Base, Ohio.
This is a Sources Sought (SS)/Request for Information (RFI) only. This is NOT a presolicitation or Request for Quote (RFQ) and is not to be construed as any commitment by the Government. This notice does not obligate the Government to award a contract and or pay for any quote preparation costs. The Government will not accept quotes at this time. This notice is not an offer by the Government to enter into a contract or any agreement. Interested Small Business concerns must identify to the Contracting Officer their interest and full capability to satisfy the Government's requirement by closing date listed. Responses will allow the Government to conduct an initial review of market capabilities in support of requirements identified in the attached Performance Work Statement (PWS) dated 17 March 2025.
SUBMISSION DETAILS: All interested parties are encouraged to submit a response to this SS/RFI. Capability packages should address the following questions:
- Company name, CAGE code, address, point of contact, phone number, and email address.
- Identification of whether the company is currently designated as a Small Business as defined in FAR Part 19.1 and the appropriate category (e.g., 8(a), HubZone, Service-Disabled, etc.).
- Company description of relevant capability and experience to provide supplies/services in accordance with the minimum requirements listed in the attached draft PWS.
- Item specifications/descriptions/brochures being offered that meet requirements listed in attached draft PWS.
- Company's potential teammates/subcontractors (if required to ensure success).
- What, if any, risks or unknowns would hinder industry’s ability to meet the requirements?
- Do you have an active GSA contract/schedule with this item available for purchase? If so, please include contract number and a copy of contract/schedule.
Capability packages shall be sent via email to Gabrielle Ruiz at gabrielle.ruiz.1@us.af.mil, by 02 May 2025 at 5:00 pm Eastern Standard Time.
The Government encourages submittal of any additional comments or suggestions that you would like to share. Please be advised that all submissions become Government property and will not be returned.
All correspondences sent via email shall contain a subject line that reads “SS-AFRL-PZLEQ-2025-0014 Technical/Research Regulatory Affairs Specialist/Subject Matter Expert for Food and Drug Administration (FDA)”. Please note that email filters at Wright-Patterson AFB are designed to filter emails without subject lines or with suspicious subject lines or contents (i.e., .exe, or .zip files). Therefore, if this subject line is not included, the email may not get through the email filters. Also be advised that .zip or .exe files are not allowable attachments and may be deleted by the email filters at Wright-Patterson AFB. If sending attachments with email, ensure only .pdf, .doc, docx, xls, or .xsls documents are sent. The email filter may delete any other form of attachments.
Files
| File | Type | Posted |
|---|---|---|
| PWS IR .4 FDA SME Contractor v2_March 2025.pdf |
Similar open opportunities
| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| FDA/CDRH Scientific Technical Capacity for Regulatory Review | FDA Office of Acquisition and Grant Services | No set-aside |
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