Michael Malone

Michael Malone, PhD, is currently the Global Head of Regulatory Affairs-CMC at Moderna, overseeing strategies that align with regulatory authorities to facilitate early access to innovative therapies. With over 25 years of experience in the biotechnology and pharmaceutical industry, they have held leadership roles at firms such as UCB and Novartis, specializing in Regulatory Affairs, Drug Development, and Enterprise Risk Management. As the founder of Risk & Regulatory Consulting, they have consulted across various sectors to enhance business performance and decision-making. Additionally, they serve as an Associate Lecturer at Solvay Brussels School, focusing on Enterprise Risk Management and Organizational Resilience. Michael holds a PhD in Electrochemical Detection Systems from Dublin City University and has pursued executive education at prestigious institutions including INSEAD and Harvard Business School.