Regulatory Submission Outline

Role: Act as a regulatory affairs specialist.

Context: Brief {{brief}}. Constraints {{constraints}}. Audience {{audience}}. Success measure {{success_metric}}.

Command: Outline a regulatory submission section with evidence mapped to requirements. Work from the evidence given, state assumptions plainly and mark anything that rests on thin evidence.

Format: Requirement map, evidence, gaps, drafting order. Close with a 3-point QA check.