A highly accomplished thought leader in global drug registration, multiregional clinical trials, and the application of AI/ML in regulatory sciences. • Professor of Practice to utilize the experience from a successful career with leading biopharmaceutical companies.• Founder of GRA Advisors to advise on drug development, registration, and multiregional clinical trials in over 100 countries through an extensive global network of regulatory experts. • Founder of Zebrafish AI, an advisory group focused on applying AI/ML in regulatory sciences. The Human Bridge to AI in Regulatory Sciences• Actively facilitated science-based regulatory policy discussions between industry and regulators to drive health authority interactions to positive outcomes. • Drafted and implemented ICH E17 guidelines on multiregional clinical trials as an expert working group member and implementation team.• Expert in bridging interfaces between discovery, development, manufacturing, medical, and commercial to promote the launch of new medicines and ensure that patient unmet needs are addressed promptly. • Published over 35 peer-reviewed journals and book chapters. Serving on various Advisory Boards. Expertise: Biopharmaceutical drug development; international markets; global regulatory affairs; multiregional clinical trials; regulatory harmonization; pharmacovigilance and drug safety; biosimilars regulations; outsourcing and offshoring; strategic partnerships; regulatory policy; establishing and managing country/regional offices; change-agent; digital; artificial intelligence;