Skills
Global R&D/ product development strategy for US, EU, IN, LATAM (BR, MX , etc.), APAC (SG, MY VN, PH, etc.), JP & MAEP/GCC understanding regulatory requirements • Global development of NME, Biologics/Biosimilar, medical device, NME/NDDS - TPP/MAP • Project, portfolio and resource - large team management globally at Internal function/CRO/CDMO
About
Pharmaceutical R&D experience of 23 years managing functions as clinical research (Ph I-IV), Pharmacovigilance, CMC Product development, regulatory, cell therapy (stem cell & CAR T), medical affairs, etc. Heading R&D department and global R&D strategy leader for ~ 14 years for USA based/global companies (Ex Head Abbott, Ferring & Amneal Group) for projects in US, EU, IN, RU, BR, MX, CN, TH, MY, JP, JO, etc. Many products approved /registered as NCE, Generics, Biologics/Biosimilars, Medical Devices and differentiated products (NDDS/LCM) with US FDA, EMA, ANVISA, CDSCO, TH-FDA, COFEPRIS, MHRA, etc. managed P&L and R&D budget of 75M$ for global product development. PhD in Medicine & Business Management Diploma (PG-DIM & PGDMM). Global regulatory development for USA (IND, BLA, ANDA, etc.), EMA, LATAM, etc. Therapeutic areas work in Oncology, Immunology, Reproductive health, Urology, Gastroenterology, Derma, Rheumatology, etc. Trained on leadership, PMBOK, LEAN management and Six Sigma. Key Achievements - Many awards, fellowships & products registered in global market, many research publications (citations >800; H-Index 11) & scientific books (2), key speakers in global scientific conferences viz. ClinOps Strategy meeting East Coast, USA 2024, PPM Summit Sep 2024 IN, 4th India Biopharma Leaders Conclave Jun 2023 IN, 18th Biosimilar Congregation 2023 IN, GMAC 2023-24 IN, etc.
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