Clinical Regulatory Expert - FDA Specialist

As a Clinical Regulatory Expert - FDA Specialist, you will validate clinical data rooms and documents against FDA evidentiary standards, author FDA information requests, and ensure compliance with deliberate defects testing regulatory judgment.

What You Will Do

Your main responsibilities will include validating clinical data rooms and documents, authoring FDA information requests, designing prompts and rubrics, and ensuring compliance with regulatory standards.

Why It Might Be a Fit

This role requires 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