Director - Regulatory Affairs
With almost a decade of expertise in global pharmaceutical regulatory affairs and holding an MSc in Chemistry (Pharmaceuticals), Lini Subin is a knowledgeable strategist who understands the entire application lifecycle, from pre-approval to post-approval activities.
Well versed in EU DC/MR and ICH national strategies, her specialities include dossier development for a variety of markets including Europe, Asia, Africa, Latin America, CIS countries and the US. She is also an expert in managing eCTD/NeeS conversions, and MA transfers.
Based in India, her insightful knowledge of market trends gives her a unique perspective on implementing business development initiatives.