Clinical Regulatory Expert

Official role description

As a regulatory expert on this project, you would own a part in multiple workflows: — 1. Clinical Data Generation: we need to validate that each data room and its documents hold up against FDA evidentiary standards and formatting expectations, including the deliberate defects planted to test regulatory judgment. — 2. FDA RFI task authorship: you must be capable of authoring information requests and model responses, and designing prompts, golden outputs, and rubrics to quantify the ability of an AI agent attempting to do the same thing. — To be qualified for this role, you must fit the following requirements: • Location: US, Canada, or France. • YOE: 5+ required. 10-25 preferred. • Education: MD, PhD, PharmD, or equivalent. • Hourly availability: 20-25 hours/week, minimum. 30+ preferred. • Experience: MUST have reviewed or responded to FDA information requests across CMC, patient-level data requests, investigator qualifications, and biomarker or endpoint evidence. Direct FDA review experience strongly preferred over sponsor-side liaison work. No conflict of interest with a current federal employer.