Prasanna K. Bhat

About Prasanna K. Bhat

Regulatory Affairs Professional with 15years of experience. To contribute substantial knowledge to the field of Clinical Research, Clinical Trial Operations, Regulatory Affairs, Regulatory Writing, Medical Affairs, Clinical Reporting, Regulatory Affairs Regulatory Operations & submissions, CDM,ICH-GCP, Bioinformatics and Computational biology.Skills:Life Cycle Management, Clinical Operations, Regulatory Operations, Query response to Health Authorities, eCTD Submissions, Tracking Submissions, Validations, CMC, Medical Devices-Insulins,Injectables Dossier Submissions, 510(k) submissions, Docubridge, ISI Toolbox, View Point,GDMS, Clinical Reporting, Regulatory Writing, OCR verification, NEES, eCTD, TOC verification, CFR, Clinical Data Analysis, PSUR, DSUR, EXTEDO, EURS, ICH-GCP, ASEAN CTD, CTMS, EDMS, IWRS, Molecular Algorithms, Next Gen.Sequencing, Bioinformatics, Molecular Modeling, Drug Docking studies.Biological Specialties: Molecular Biology, Proteomics, Bio assay development, PCR, DNA extraction, Electrophoresis, X-Ray Diffraction, HPLC, GC, LC-MS, SDS-PAGE, Clinical Trails, Sequence Analysis, Modelling, Bioperl, Molecular Modelling, Docking, Computational Drug Discovery

Experience

1. Manager- Compliance Cmc-conformance- Regulatory Change Management

   Pfizer

   Jan 2021 — Present · Tamil Nadu, IN

   Regulatory Change Management, CMC Change Control Management, Life Cycle Management, IND/CTA,NDA,ANDA,BLA,Annual Reports- Dossier Compilation,review & Submissions for USA-FDA,EU-EMA,Canada,ACTD and ROW Markets. Compliance, Agency Query Management, Variations & Post Approval Changes

Education

• VMU

  Master of Philosophy, Bioinformatics

  2008 — 2009

• Kuvempu Vishwavidyanilaya

  Master’s Degree, Biomathematics, Bioinformatics, and Computational Biology

  2005 — 2007

• Karnatak University

  Bachelor's Degree, Chemistry, Botany, Zoology

  2002 — 2005

• Kuvempu Vishwavidyanilaya

  Master's degree, Biomathematics, Bioinformatics, and Computational Biology

  2005 — 2007

Skills

• Structural Bioinformatics
• Vaccines
• Docking
• Polymerase Chain Reaction (Pcr)
• Medical Writing
• Life Sciences
• Validation
• Biotechnology
• Standard Operating Procedure (Sop)
• Adme
• Pharmacovigilance
• High-Performance Liquid Chromatography (Hplc)
• Molecular & Cellular Biology
• Drug Discovery
• Hplc-Ms
• Bioassay
• Regulatory Affairs
• Sequence Analysis
• Chemistry
• Regulatory Submissions
• Data Mining, Drug Discovery, Molecular Biosimulation, Biopathway Network Design
• Clinical Trials
• Elisa
• Pharmaceutical Industry
• Clinical Trial Management System (Ctms)
• Nces
• Drug Development
• Clinical Development
• Assay Development
• Building Biological Pathways, Computaional Biology, Systems Biology,
• Structural Biology
• CRO Management
• Bioinformatics
• Drug Metabolism
• Ich-Gcp
• Molecular Biology
• Clinical Research
• Drug Regulatory Affairs
• Proteomics