Michael Cheung

Strategic Executive Leader with 20 years of experience directing US REMS, product safety, and risk management across the full product lifecycle. As a primary US authority for safety governance, I specialize in leading high-stakes FDA negotiations and designing complex REMS programs that balance regulatory rigor with patient-centric outcomes. Proven success in driving cross-functional alignment across Medical, Regulatory, and Commercial teams to ensure inspection readiness and the execution of scalable risk minimization strategies.As a Risk Management, Patient Safety, and Medical Affairs and Operations Leader, I am known for:☑ Building trust, influence, and relationships within large, diverse, matrixed organizations☑ Global program development, rollout, and direction☑ Expanding global risk management and REMS programsMY WHEELHOUSE: Global Risk Management, Patient Safety and Medical Affairs Programs ➪ Phase I-IV Clinical Drug Development, Safety & Risk Management ➪ Clinical Research & Project Management ➪ Risk Evaluation & Mitigation Strategy Programs (REMS) ➪ Pharmaceutical Industry