Clinical Regulatory Expert

Great Value Hiring; United States; On-site; USD 179,000 - 234,000; Full time

Job summary

Great Value Hiring is seeking a Clinical Regulatory Expert to drive FDA-related workflows on a complex project. You will own data-generation validation against FDA evidentiary standards and contribute to the integrity of documents in data rooms.

The role requires 5+ years of experience (10–25 preferred), MD/PhD/PharmD or equivalent, and ability to author RFIs, craft model outputs, and design rubrics to quantify AI-assisted regulatory tasks. Remote work options may apply.

Qualifications

• Location: US, Canada, or France.
• YOE: 5+ years required; 10–25 preferred.
• Hourly availability: 20–25 hours/week minimum; 30+ preferred.
• Experience: Reviewed or responded to FDA information requests across CMC, patient-level data requests, investigator qualifications, and biomarker or endpoint evidence.

Responsibilities

• Own data-generation workflows to validate FDA evidentiary standards.
• Author FDA RFIs and design prompts, rubrics, and outputs.

Skills

FDA RFI experience

Regulatory data review

Clinical data generation

Education

MD/PhD/PharmD or equivalent

Job description

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.