Gyanaranjan Satyabrata Routaray
Deputy Manager- Regulatory Affairs - Us & Canada @Cipla
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WORK HISTORY
Deputy Manager- Regulatory Affairs - Us & Canada @Cipla
Mumbai, IN
Pre-IND, IND submission, Pre- ANDA, ANDA, NDA submission, section 505 (b)(2),NCE-1, CGT pathway submission for Complex molecules (Peptides, Bio similars), Solid oral, Liquid, Parenteral,respiratory, semi solid dosage forms- Handling submission of response to defficiency (DRL,IR,CRL etc.) and ammendments- Handling of Product correspondence, controlled correspondence, patent certificate ammendments, labelling ammendments and Drug listing and delisting-Regulatory Affairs activitie post approval Product Life cycle Management (PAS, CBE-30, CBE-0 and Annual Reports)for approved NDAs,ANDAs.
EDUCATION
Biju Patnaik University of Technology, Odisha
Bachelor of Pharmacy - BPharm, Pharmacy
Biju Patnaik University of Technology, Odisha
Master of Pharmacy (M.Pharm), Pharmaceutics and Drug Design
ABOUT GYANARANJAN SATYABRATA ROUTARAY
Accomplished Regulatory Affairs Leader with 10+ years of expertise in U.S. FDA…
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