Lini Subin

Background

About Lini Subin

Highly accomplished regulatory affairs leader with a proven track record in developing and executing global regulatory strategies for advanced therapies, including biologics, generics, or new medicines. Expertise in CMC (Chemistry, Manufacturing, and Controls), regulatory intelligence, and complex product development, with a focus on navigating diverse regulatory frameworks across global markets (e.g, FDA, EMA, MHRA, etc.). Skilled in providing strategic support for pre- and post-approval regulatory processes, ensuring compliance with evolving regulations, and driving successful product approvals in highly competitive markets. Adept at leading cross-functional teams to address regulatory challenges, optimize submission pathways, and accelerate time-to-market for innovative therapies. Passionate about advancing cutting-edge treatments while maintaining rigorous compliance and fostering collaboration with global regulatory agencies and stakeholders.Acted as Regulatory Strategist/Subject Matter Expert (CMC & RA) to internationally recognized pharmaceutical companies in dossier development & regulatory submissions for successful marketing authorization in the regulated markets. Proven track record as Regulatory Affairs operational lead at the management level in execution and delivery of regulatory services effectively utilizing the resources. Now look forward to have senior level assignments in global regulatory affairs as a consultant or board member.