Deepak Jain
Associate Director - Global Regulatory Affairs at Alvotech ehf
- Role
- Associate Director - Global Regulatory Affairs at Alvotech
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Deepak Jain
End to end regulatory expertise in the product portfolio i.e Pharmaceuticals, Biologics, Recombinant Biotech and Biosimilar.
Experience
Associate Director - Global Regulatory Affairs
Aug 2025 — Present · Mumbai, IN
Education
Indira Gandhi National Open University
Master of Business Administration (MBA)
2008 — 2012
Parul University, Vadodara
Doctor of Philosophy - PhD (Pursuing) , Pharmacology
2024
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor in Pharmaceutical Science (B.Pharma), Pharmacy
2004 — 2008
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Master in Pharmaceutical Science (M.Pharma), Pharmacology
2009 — 2011
Skills
- Copyright
- Review of Clinical Documents
- Regulatory Filings
- Product Registration
- Trade Compliance
- Technology Transfer
- Trademark
- Cdsco/Dcgi/Fda Compliance & Quires Handling
- Regulatory Affairs
- Pic's
- Copp
- Regulatory Guidelines
- Documents Review Concern with Gmp or Cgmp
- Objection Resolution
- Adr Compilation
- Regulatory Requirements
- Iso & Directive
- Cder
- Drug & Cosmetic Act & Rules
- Cmc
- Rational Studies
- Labelling Review
- Pre-Clinical Data Compilation & Review
- Validation
- Dmf
- Variance Study
- Gmp
- U.s. Food and Drug Administration (Fda)
- Nda
- Patent
- Documents Review R&D, F&D, Clinical
- Compliance
- Pmf
- Regulatory Submissions
- Regulated & Semi-Regulated Market
- Sop
- Risk Assessment
- Ipr
- Ctd/Ectd
- Standard Operating Procedure (Sop)
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