Kabir Ahluwalia

CMC Regulatory Affairs Manager, Amgen

Kabir Ahluwalia, PhD, is a CMC Regulatory Affairs Manager at Amgen Inc., Thousand Oaks, CA. He leads initiatives in regulatory modernization, digitization, and the integration of AI and emerging technologies. Kabir is the Product Owner for GenAI tools within the Regulatory CMC domain and leads the development of the GenAI platform for Global Regulatory. His efforts have led to the launch of Amgen's first GenAI tool, which significantly reduces the time required to generate a Quality Overall Summary. In addition to his primary responsibilities, Kabir contributes to Amgen’s Advocacy & External Engagement function, facilitating collaboration within and beyond Amgen to advance initiatives in CMC acceleration and regulatory technology implementation. He also serves on the steering committee for the ISPE Community of Practice on AI, focusing on the safe adoption of AI technology in the industry. Kabir has co-authored a peer-reviewed article on the future of CMC regulatory submissions and is currently authoring a manuscript on the application of AI in regulatory processes. Kabir holds a PhD in Clinical and Experimental Therapeutics and a MS in Regulatory Science from the University of Southern California Mann School of Pharmacy.