Nitin Prajapati
Regulatory Affairs Manager @USV PRIVATE LIMITED
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WORK HISTORY
Regulatory Affairs Manager @USV PRIVATE LIMITED
Mumbai, IN
EDUCATION
SARVJANIK PHARMACY COLLEGE, MEHSANA 245
Bachelor of Pharmacy - BPharm
SHRI B.M.SHAH COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH, MODASA 252
Master of Pharmacy, Pharmaceutical Analysis
SKILLS
ABOUT NITIN PRAJAPATI
A pharma professional with post graduate degree in pharmacy and 10 + years of experience in Regulatory Affairs for EU/UK/CA markets. Responsibility for the registration and successful delivery of new/generic/hybrid products from product identification up to commercial launch. An expert in regulatory strategy planning, risk analysis, regulatory procedure management, reporting and delivery of a range of projects including in-licensed and development projects. Experience of working with multiple clients/third party CMOs based business model.CMC expert, dossier writing and review with experience of working in close association with R&D/formulation development teams. Line management experience.Has filed several European MA Applications through National/MRP/DCP procedures and responded to the deficiencies raised by the Regulatory Agencies.Rich experience in life cycle management like filling post approval variations (Type IA, IB and II), renewals, labelling updates and eCTD applications etc.
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