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Mohit Khandelwal

Mohit Khandelwal

Student

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location of Mohit KhandelwalBengaluru, Karnataka, India

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  • Timeline

  • About me

    Experienced Regulatory Affairs Professional | Veeva Vault | LCM Leader | Regulatory Compliance| People Manager | Industry focused AI Leader

  • Education

    • AstraZeneca

      2022 -
      Internal training courses and workshops

      Activities and Societies: Influencing and Negotiating, Advanced Buisness Communication skills Influencing and Negotiating, Advanced Business Communication skills, Experiential Interviewer

    • Eli Lilly and Company

      2020 - 2022
      Internal courses

      Gold Level - Business Information Security, Time management & time boxing, lean and six Sigma, Stakeholder management

    • Jiwaji University Gwalior

      2003 - 2007
      B. Pharm pharmacy

      Bachelor in Pharmacy

    • Manipal Academy of Higher Education

      2007 - 2009
      M.S. Regulatory Affairs Pharma Regulatory Affairs

      The degree programme is composed of verticals that shape a student appropriately fit for Regulatory Affairs job.

  • Experience

    • MCOPS

      Jan 2007 - Jan 2009
      Student

      Student in Dept of Pharmaceutical Regulatory Affairs

    • Alkem Pharmaceuticals, Daman (U.T.)

      Sept 2007 - Oct 2007
      Trainee Officer Production

      In past i have served as a Trainee Production Officer , Alkem Pharmaceuticals , Gujarat. After serving for 2 months i resigned and moved to Manipal University to pursue higher education.

    • India Medtronic Pvt. Ltd.

      Nov 2008 - Apr 2009
      Trainee Regulatory Affairs ,Reimbursement and KAM

    • Ranbaxy

      Jan 2009 - Mar 2014

      Looks after the Prescription drug products Registration and Product Life cycle Management in European Union, Australia and New Zealand markets. 1. Well versed with registration procedures in EU union and other regulated markets like- NZ, Australia. 2. Comprehensive knowledge in handling EU regulatory compliance activities.3.Well versed with preparation of dossiers, stability record & resolve the queries raised by Regulatory Authorities, Hospital/Pharmacy, Partners/Customers and Patients etc.

      • Research Scientist

        May 2009 - Mar 2014

      • Ranbaxian

        Jan 2009 - Jan 2010

    • Kinapse

      Apr 2014 - Nov 2019

      Responsible for Post approval life cycle management of products in EU and Emerging markets.

      • Senior Regulatory Scientist

        Mar 2018 - Nov 2019

      • Regulatory Scientist

        Mar 2016 - Mar 2018

      • Sr Regulatory Associate

        Apr 2014 - Mar 2016

    • Biocon

      Dec 2019 - Sept 2020
      Regulatory Affairs Project Manager

      CMC API, RIM tools

    • Eli Lilly and Company

      Sept 2020 - Aug 2022
      Regulatory Affairs Manager

      CMC RA Project Manager (Biotech - DS n DP)

    • AstraZeneca

      Aug 2022 - now
      Associate Director Regulatory Affairs

  • Licenses & Certifications

    • Gemerative AI Accreditation Programme

      AstraZeneca
      Jul 2024

    • RAPS Member

      Regulatory Affairs Certification Program
      Jan 2020
      View certificate certificate