Regulatory Affairs Scientist

ABOUT THE PROGRAM

The Office of Regulatory Activities (ORA) provides regulatory and clinical support across the full life cycle of FDA-regulated medical products sponsored by the Department of Defense. This position supports ORA on site at Fort Detrick, Maryland, working alongside government scientists, clinicians, and regulatory professionals under the DHA Research and Development / USAMRDC enterprise.

THE ROLE

Serve as regulatory subject matter expert for assigned DoD-sponsored products, supporting submissions to and communications with FDA. This is the largest single opening on the program, with seven positions available.

WHAT YOU WILL DO

•      Provide regulatory subject matter expertise on assigned projects and keep leadership current through periodic reports.

•      Support integrated product teams, advising on FDA-related activities and issues.

•      Contribute to written regulatory strategies describing the pathway to approval, licensure, or clearance.

•      Create and maintain Target Product Profiles.

•      Review, analyze, and respond to FDA communications by regulatory deadlines.

•      Prepare, review, and archive regulatory submission documents in EDMS.

•      Register and maintain studies in ClinicalTrials.gov and verify records at required intervals.

•      Identify and mitigate regulatory risk through a project Risk Register.

WHAT YOU NEED

•      3-7 years in regulatory affairs supporting FDA-regulated products.

•      Working knowledge of 21 CFR 312 and 21 CFR 812.

•      Experience preparing regulatory submission content.

•      Clear written communication for FDA-facing documents.

•      Education - Bachelor's, Master's, or PhD in a life science or related discipline

•      Tools - eCTD, ClinicalTrials.gov, EDMS, Risk Registers, Microsoft Office

•      Investigation - T1 / HSPD-12 credentialing (or interim) favorably adjudicated by DCSA prior to start. Investigation cost is covered by the Government.

NICE TO HAVE

•      Exposure to CDER, CBER, or CDRH submissions.

•      RAC certification or in progress.