Regulatory Affairs Consultant - Fully Remote | Upto $170/hr

About The Job Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam D'Angelo, Larry Summers, and Jack Dorsey. Position: Clinical Regulatory Expert Type: Contract Compensation: $130–$170/hour Location: Remote Commitment: 20–25 hours/week Role Responsibilities Validate clinical data rooms and documents against FDA evidentiary standards and formatting expectations. Author FDA information requests and model responses. Design prompts, golden outputs, and rubrics to quantify AI agent capabilities. Ensure compliance with deliberate defects testing regulatory judgment. Work independently and asynchronously to meet deadlines and improve AI model performance. Qualifications Must-Have 5+ years of experience in regulatory roles. MD, PhD, PharmD, or equivalent. Experience reviewing or responding to FDA information requests across CMC, patient-level data, investigator qualifications, and biomarker or endpoint evidence. No conflict of interest with a current federal employer. Preferred 10–25 years of experience. Direct FDA review experience preferred over sponsor-side liaison work. Application Process (Takes 20–30 mins to complete) Upload resume AI interview based on your resume Submit form Resources & Support For details about the interview process and platform information, please check: https://talent.docs.mercor.com/welcome For any help or support, reach out to: [email protected] PS: Our team reviews applications daily. Please complete your AI interview and application steps to be considered for this opportunity. ,

Validate clinical data rooms against FDA standards and author information requests and model responses. Design prompts and rubrics to quantify and improve the performance of AI agents in regulatory judgment.

Requires an MD, PhD, or PharmD with at least 5 years of regulatory experience, preferably with direct FDA review experience. Must have expertise in reviewing CMC, patient-level data, and biomarker evidence without conflicts of interest with federal employers.

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• FDA Regulatory Compliance
• Clinical Data Validation
• FDA Information Requests
• CMC
• Biomarker Evidence
• Endpoint Evidence
• AI Prompt Design
• Regulatory Judgment
• Clinical Documentation
• Asynchronous Work

• Consulting
• Healthcare
• Legal
• Science & Research
• Software

Formation minimale

Maîtrise

Expérience minimale

10+ ans

Postuler avant le

19 sept. 2026

Langue de l’offre

anglais

Heures de travail

25 heures par semaine

Exigences de lieu

Country, Greater Montreal Metropolitan Area

Niveau d’expérience

Not Applicable