Senior Manager, Regulatory Affairs at Syngene International Limited
Industry
Medical / Health Care / Pharmaceuticals
About
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:
鈥� Biosimilar target product profile, biosimilar specifica...
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