Deepak Jain
Associate Director - Global Regulatory Affairs @Alvotech
Mumbai, MH, IN
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MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Aug 2025 — Present
Associate Director - Global Regulatory Affairs @Alvotech
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Mumbai, IN
EDUCATION
2008 — 2012
Indira Gandhi National Open University
Master of Business Administration (MBA)
2024
Parul University, Vadodara
Doctor of Philosophy - PhD (Pursuing) , Pharmacology
2004 — 2008
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor in Pharmaceutical Science (B.Pharma), Pharmacy
2009 — 2011
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Master in Pharmaceutical Science (M.Pharma), Pharmacology
SKILLS
CopyrightReview of Clinical DocumentsRegulatory FilingsProduct RegistrationTrade ComplianceTechnology TransferTrademarkCdsco/Dcgi/Fda Compliance & Quires HandlingRegulatory AffairsPic'sCoppRegulatory GuidelinesDocuments Review Concern with Gmp or CgmpObjection ResolutionAdr CompilationRegulatory RequirementsIso & DirectiveCderDrug & Cosmetic Act & RulesCmcRational StudiesLabelling ReviewPre-Clinical Data Compilation & ReviewValidationDmfVariance StudyGmpU.s. Food and Drug Administration (Fda)NdaPatentDocuments Review R&D, F&D, ClinicalCompliancePmfRegulatory SubmissionsRegulated & Semi-Regulated MarketSopRisk AssessmentIprCtd/EctdStandard Operating Procedure (Sop)
ABOUT DEEPAK JAIN
End to end regulatory expertise in the product portfolio i.e Pharmaceuticals, Biologics, Recombinant Biotech and Biosimilar.
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