Istanbul, Türkiye
I am an International Regulatory Affairs professional with over 7 years of experience in the pharmaceutical industry, specializing in global regulatory strategy, international product registrations, CMC documentation, and lifecycle management across regulated and emerging markets. Currently, I lead international regulatory activities across multiple global markets, supporting registration planning, dossier development, regulatory compliance, and product lifecycle management. My experience spans a broad international footprint, covering Europe, the Middle East, Asia-Pacific, and other strategic territories. I have extensive expertise in CTD/eCTD dossier preparation and review, particularly Module 3 (3.2.S and 3.2.P), as well as health authority interactions, regulatory intelligence, and market access support. I actively follow global regulatory developments and industry trends, and have participated in international pharmaceutical events including CPHI Frankfurt (2025) and CPHI & PMEC India (2026). My professional focus is on building sustainable regulatory strategies, supporting international growth, and translating complex regulatory requirements into practical business solutions. Core expertise: • Global Regulatory Strategy • International Market Authorizations • CTD / eCTD & CMC (Module 3) • Lifecycle & Variation Management • Health Authority Interactions • Regulatory Operations Leadership • Team Development • Portfolio & Market Expansion Strategy I am always interested in connecting with professionals in Regulatory Affairs, Pharmaceutical Development, Quality, Market Access, and International Business Development.