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Ashutosh Pandey

Ashutosh Pandey

TECHNICAL DATA ASSOCIATE, Drug Regulatory Affairs

Followers of Ashutosh Pandey1000 followers
location of Ashutosh PandeyMumbai, Maharashtra, India

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  • Timeline

  • Skills

    Regulatory affairs
    Pharmacovigilance
    Clinical trials
    Regulatory submissions
    Formulation
    Regulatory requirements
    Pharmaceutical industry
    Gmp
    Ctd
    Cmc regulatory affairs
    Sop
    Fda
    Biopharmaceuticals
    Gcp
    Drug safety
    Pharmaceutics
    Anda

  • About me

    Knowledge of Regulatory submissions to Drugs Controller General of India (DCGI), RCGM/ IBSC. Sound knowledge of Marketing Authorization of the products (Biologicals/Biosimilar & Pharma), CMC, Import & Registration of New Drugs, Medical Devises, Cosmetics, Clinical Trials (from Phase I to Phase IV), Global Clinical Trials, Fixed Dose Combinations (FDCs), PMS study, PSUR, Risk Management Plan, NOC for Form 29, post approval changes/variations and Bioequivalence study as per Drugs & Cosmetics Act and well aware with SUGAM online submissions and Schedule Y and current guidelines/notifications. Possess knowledge in various regulations pertaining to Drugs & Cosmetics Rules 1945 and relevant Acts, IBSC guidelines including on functioning of DCG (I), CDSCO zonal office, DBT etc.

  • Education

    • Chaudhary Charan Singh University

      2002 - 2005
      Bachelor of Science (B.Sc.) Biotechnology

    • Vinayaka Mission's Research Foundation - University

      2009 - 2011
      Master of Science (M.Sc.) Biochemistry

    • Cranfield University

      2006 - 2008
      Master of Science (M.Sc.) Clinical Research

  • Experience

    • CDSCO, HQ (Office of DCGI)

      Jul 2008 - Aug 2011
      TECHNICAL DATA ASSOCIATE, Drug Regulatory Affairs

      Gained EXPERIENCE in Global Clinical Trial, New Drugs, Fixed Dose Combination (FDC), PMS study, BA/BE study, import and registration, medical devices dept. in DCGI office

    • Biocon

      Sept 2011 - Sept 2015
      Sr. Executive -Drugs Regulatory Affairs

      A sound knowledge of CMC, MAA (Module 1 to 5), Clinical Trials, Global Clinical Trials, Fixed Dose Combinations (FDCs), PMS study, Import & Registration of the products, Marketing Authorization of the products and Bioequivalence study as per Drugs & Cosmetics Act and well aware with Schedule Y

    • PharmaVigilance Limited

      Sept 2015 - Jun 2016
      Assistant Manager -Regulatory Affairs & PV

      Looking for Europe Market

    • Biocon Biologics

      Jul 2016 - May 2020
      Assistant Manager - Drugs Regulatory Affairs

    • Glenmark Pharmaceuticals

      Jun 2020 - Mar 2022
      Manager - Drug Regulatory Affairs

      Knowledge of Regulatory submissions to Drugs Controller General of India (DCGI), RCGM/ IBSC. Sound knowledge of Marketing Authorization of the products (Biologicals/Biosimilar & Pharma), CMC, Import & Registration of New Drugs, Medical Devises, Cosmetics, Clinical Trials (from Phase I to Phase IV), Global Clinical Trials, Fixed Dose Combinations (FDCs), PMS study, PSUR, Risk Management Plan, NOC for Form 29, post approval changes/variations and Bioequivalence study as per Drugs & Cosmetics Act and well aware with SUGAM online submissions and New Drugs and Clinical Trial Rules, 2019. Show less

    • Alkem Laboratories Ltd.

      Mar 2022 - now
      Senior Regulatory Affairs Professional

  • Licenses & Certifications

    • PGDPM

      UPDESCO