The 5-level, role-by-role AI certification for the people who actually ship the dossier: regulatory affairs, medical writers, MSLs, clinical operations, pharmacovigilance writers, and CMC. Built for the post-January-2026 world where FDA and EMA finally agree on what 'good AI practice' looks like inside a regulated submission. Every lesson moves a named artifact a real desk owns: Module 2.5 Clinical Overview, CSP under ICH M11, ICSR narrative under E2B(R3), comparability protocol under ICH Q5E, Type C briefing book, FDA Form 483 response, PSUR under ICH E2C(R2), and the AI section of the cover letter.