On Thursday, October 9, 2025, the College of Pharmacy at Gulf Medical University hosted an online faculty research seminar delivered by Dr. Saroj K. Roy, Ph.D., Manager of Global Regulatory Affairs, Innovation CMC, at Elano Innovation and Alliance Centre, India. The session was attended by faculty members from the Pharmaceutical Sciences Department and graduate candidates from the Master’s in Drug Discovery and Development (MDD) program.
Titled “Understanding Drug Regulatory Affairs: Basics, Processes & Global Perspectives” the seminar provided an in-depth overview of the key principles and global frameworks governing pharmaceutical regulation. Drawing on more than 15 years of experience in global pharmaceutical submissions and lifecycle management, Dr. Roy shared insights from his work with major companies including Novartis, Eli Lilly, Mylan, and Johnson & Johnson.
He discussed strategies for regulatory compliance, dossier preparation, and change control across diverse markets such as the EU, US, LATAM, GCC, ANZ, and APAC regions. The presentation highlighted the importance of aligning regulatory operations with evolving international standards to ensure the quality, safety, and efficacy of pharmaceuticals.
The seminar concluded with an engaging Q&A session, during which participants explored the challenges and opportunities shaping the future of global regulatory affairs. The event provided attendees with valuable perspectives on the intersection of innovation, compliance, and global health policy within the pharmaceutical industry.
Aligned with the United Nations Sustainable Development Goals (SDGs):
SDG 4: Quality Education; SDG 8: Decent Work and Economic Growth; SDG 9: Industry, Innovation and Infrastructure
