Regulatory Affairs Consultant

As a Regulatory Affairs Consultant, you will work independently and asynchronously to validate clinical data rooms and documents against FDA evidentiary standards and formatting expectations. You will also author FDA information requests and model responses, design prompts, golden outputs, and rubrics to quantify AI agent capabilities. The role requires compliance with deliberate defects testing regulatory judgment.

What You Will Do

Your day-to-day responsibilities will include validating clinical data rooms and documents, authoring FDA information requests, designing prompts and rubrics, and ensuring compliance with regulatory judgment.

Why It Might Be a Fit

This role may be a fit for you if you have 5+ years of experience in regulatory roles, an MD, PhD, PharmD, or equivalent, and experience reviewing or responding to FDA information requests.

Requirements

• 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