The Institute of Pharmacy, Nirma University, successfully organized an expert lecture on “Regulatory Affairs in Practice: Open Discussion” on 24th December 2025. The session was delivered by eminent expert Dr. Mitul Chatterjee, Director – Regulatory Affairs at Baxter International Inc., Ahmedabad.
The lecture was conducted as an interactive discussion focusing on current regulatory affairs practices, pharmaceutical industry expectations, and the evolving role of regulatory professionals. Dr. Mitul shared practical insights into generic product development and approval, including ANDA submissions, regulatory strategy, lifecycle management, and post-approval changes. She emphasized that timely planning, strong regulatory intelligence, and effective cross-functional coordination are critical for achieving faster approvals while ensuring regulatory compliance.
The session also highlighted the scope and career opportunities in regulatory affairs, outlining essential skill sets such as a sound understanding of global regulatory guidelines, regulatory writing, strategic thinking, data interpretation, and familiarity with digital submission systems. The importance of effective communication with regulatory authorities and the ability to adapt to evolving regulatory requirements was strongly emphasized.
Overall, the lecture provided valuable industry-oriented perspectives, helping students bridge the gap between academic learning and real-world regulatory practice, and preparing them for careers in pharmaceutical regulatory sciences.
This lecture was coordinated by Dr. Charmy Kothari, Associate Professor, Institute of Pharmacy, Nirma University for B.Pharm and M.Pharm students studying Regulatory Affairs.