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Bengaluru Area, India India

Senior Manager, Regulatory Affairs at Syngene International Limited

Medical / Health Care / Pharmaceuticals

Regulatory Affairs professional with over 15 years of industrial hands-on experience; spanning from quality, regulatory - small molecule and biological drug substance and biological drug products, including novel and predominantly into niche biosimilar product strategy and development for developed markets as well as emerging markets. Actively involved in the many-first-in-company ventures, viz., Biosimilar development, Novel Biological regulatory submissions, partner due diligence, Japanese accreditation, US INDs, EU CTAs, DS support to EU procedures including biological, electronic submissions and many more Key involvement in: • Biosimilar target product profile, biosimilar specifica...