Clinical Regulatory Expert

Clinical Regulatory Expert [$130-$170/hr] As a regulatory expert on this project, you would own a part in multiple workflows: 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. 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.

The expert will validate clinical data rooms against FDA standards and author information requests and model responses. Additionally, they will design prompts and rubrics to evaluate the performance of AI agents in regulatory tasks.

Candidates must have an MD, PhD, or PharmD with at least 5 years of experience, preferably 10-25 years. Direct experience reviewing or responding to FDA information requests across CMC and patient-level data is mandatory.

Identified from the job description. Confirm important requirements above.

• Clinical Data Generation
• FDA Evidentiary Standards
• FDA RFI Authorship
• Prompt Design
• CMC Review
• Patient-Level Data Analysis
• Biomarker Evidence
• Endpoint Evidence
• Regulatory Judgment
• AI Agent Evaluation

• Healthcare
• Science & Research
• Legal
• Manufacturing
• Consulting

Minimum education

Master’s degree

Minimum experience

10+ years

Posting language

English

Working hours

30 hours per week

Seniority

Mid-Senior level

Application method

Direct apply is available