Director of Regulatory Affairs | Remote

Responsibilities

• Validate clinical data rooms and documents against FDA evidentiary standards and formatting expectations.
• Identify and assess deliberate defects in data to test regulatory judgment.
• Author FDA information requests and model responses.
• Design prompts, golden outputs, and rubrics for AI agent evaluation.

Requirements

• Strong relevant experience in reviewing or responding to FDA information requests.
• Hold an MD, PhD, PharmD, or equivalent.
• Experience in FDA review preferred over sponsor-side liaison work.
• No conflict of interest with a current federal employer.

Compensation: $130–$170 per hour. Location: Remote.