Project Manager

Saswata Ray is a regulatory medical writer, health informatics researcher, and project manager with over a decade of experience spanning clinical research, pharmacovigilance, and digital health. Holding a PhD in Health Informatics from the University of Auckland and PRINCE2 certification, his work bridges the rigour of evidence-based medicine with the operational demands of global regulatory submissions — across US FDA, EMA, and Australian TGA frameworks. His professional portfolio includes IND/NDA documentation, pharmacovigilance safety narratives, clinical data management, and strategic project delivery for major pharmaceutical sponsors. He has worked across complex, multinational research environments where precision in language and integrity of data are non-negotiable. Alongside his regulatory career, Saswata brings a sustained engagement with the scholarship of health systems, digital transformation in clinical research, and the evolving role of AI in regulatory science. He writes with the conviction that clarity of thought and clarity of expression are inseparable — a principle that defines both his scientific output and his broader intellectual practice. Based in Auckland, New Zealand.