FDA Regulatory Expert: Clinical Data & RFI Specialist

Mercor; New York (NY); On-site; USD 83,000 - 152,000; Part time

Job summary

Mercor is seeking a regulatory expert to own multiple workflows, ensuring FDA evidentiary standards are met during clinical data generation and RFI responses. You will design prompts, rubrics, and golden outputs to assess AI performance on regulatory tasks.

Requirements include 5+ years of regulatory experience, MD/PhD/PharmD or equivalent, and 20–25 hours/week with 30+ preferred. Location flexibility includes US, Canada, or France.

Qualifications

• 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.

Responsibilities

• Own regulatory workflows across multiple projects and datasets.
• Draft and review FDA RFIs, responses, and model prompts to evaluate AI capabilities in regulatory contexts.
• Collaborate with clinical, data, and QA teams to ensure FDA evidentiary standards are met.

Skills

Regulatory experience

FDA information requests

Clinical data review

Education

MD, PhD, PharmD, or equivalent

Job description

Mercor is seeking a regulatory expert to own multiple workflows, ensuring FDA evidentiary standards are met during clinical data generation and RFI responses. You will design prompts, rubrics, and golden outputs to assess AI performance on regulatory tasks.

Requirements include 5+ years of regulatory experience, MD/PhD/PharmD or equivalent, and 20–25 hours/week with 30+ preferred. Location flexibility includes US, Canada, or France.