Clinical Regulatory Expert

Location: US, Canada, or France

Hourly rate: $130–$170/hr

Hours per week: 20–25 minimum; 30+ preferred

About the role

As a regulatory expert on this project, you will own key parts of multiple workflows:

• Clinical Data Generation: validate that each data room and its documents meet FDA evidentiary standards and formatting expectations, including deliberate defects planted to test regulatory judgment.
• FDA RFI task authorship: author information requests and model responses, and design prompts, golden outputs, and rubrics to quantify the ability of an AI agent performing the same tasks.

Requirements

• 5+ years of relevant experience (10–25 years preferred).
• MD, PhD, PharmD, or equivalent terminal degree.
• 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 is strongly preferred over sponsor-side liaison work.
• No conflict of interest with a current federal employer.