Regulatory Affairs Consultant

Job overview

The Regulatory Affairs Consultant role is remote, with a commitment of 20–25 hours per week. Compensation is $130–$170 per hour. Mercor connects creative and technical talent with AI research labs. The consultant applies clinical regulatory expertise to validate documents against FDA standards and develop information requests, responses, prompts, and evaluation rubrics. This work tests regulatory judgment and supports improved AI model performance.

What you'll do

• Validate clinical data rooms and documents against FDA evidentiary and formatting standards
• author FDA information requests and model responses
• design prompts, golden outputs, and rubrics to assess AI agent capabilities
• work independently and asynchronously to meet deadlines.

What we're looking for

Skills & competencies

regulatory affairs

clinical regulatory

fda

ai evaluation

remote

mercor

clinical data

fda information requests

regulatory judgment

20–25 hours per week

ai model performance

Work arrangement

• Weekend coverage required

Why this role

Five or more years of regulatory experience and an MD, PhD, PharmD, or equivalent are required. Experience reviewing or responding to FDA information requests across CMC, patient-level data, investigator qualifications, and biomarker or endpoint evidence is required.

About the employer

Mercor is hiring for this role. Industry: All Other Professional, Scientific, and Technical Services. Sector: 54.