About
The Certification in Global Regulatory Affairs is a 6-hour self-paced course that prepares you to work confidently in the high-demand field of international regulatory affairs. You’ll learn how to navigate complex approval processes for drugs and devices, master global submission formats, and stay compliant with health authorities worldwide. You’ll learn how to: • Understand the full lifecycle of regulatory affairs for pharma and medical devices • Work with global submission formats: CTD, eCTD, ACTD • Navigate regulations of US FDA, EMA, CDSCO, TGA, PMDA, and other agencies • Prepare dossiers, labeling, post-approval filings, and handle regulatory queries • Build regulatory intelligence and audit readiness skills Who is this for? Graduates in pharmacy, life sciences, biotech, regulatory sciences, or professionals aiming for RA roles like Regulatory Affairs Associate, Officer, or Dossier Specialist. What’s included? • Sample CTD and eCTD structure diagrams • Submission checklists and regulatory timelines for multiple countries • RA query-response templates and variation filing formats