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Harshad Wankhede

Harshad Wankhede

Trainee Regulatory affairs

Followers of Harshad Wankhede1000 followers
location of Harshad WankhedeMumbai, Maharashtra, India

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  • Timeline

  • About me

    Manager Regulatory Affairs at Teva Pharmaceuticals

  • Education

    • University Department of Pharmaceutical sciences, RTM Nagpur University

      2012 - 2014
      M-Pharma Pharmaceutics A

  • Experience

    • Glenmark Pharmaceuticals

      Jan 2015 - Jul 2015
      Trainee Regulatory affairs

      • To search USFDA, EMC and MHRA data base for innovator SmPC and PIL.• To prepare gap analysis between innovator PIL and generic PIL.• To update PIL as per innovator PIL and Pharmacovigilance recommendations.• To co-ordinate with IPR team in order to avoid Patent infringement in respective country.

    • Brill Pharma Mumbai (Subsidiary of Bristol Lab. UK)

      Jul 2015 - Jan 2017
      Regulatory Affairs Officer (Europe market)

      • Filing of post approval quality variations in order to manage product life cycle• Submission of respective variation query response• To review Master MBR, process validation protocol, process validation reports & Annual product quality review.• Reviewing of Product development report, Analytical documents, stability study protocol and reports. • To maintain regulatory database in eCTD format.• To develop regulatory Labelling and Artworks

    • Teva Pharmaceuticals

      Jan 2017 - now

      • Manager Regulatory Affairs

        Jan 2023 - now

      • Group Leader Regulatory Affairs

        Dec 2020 - Jan 2023

      • Regulatory Affairs Associate - II

        May 2019 - Dec 2020

      • Regulatory Affairs Associate - I

        Jan 2017 - May 2019

  • Licenses & Certifications

  • Honors & Awards

    • Awarded to Harshad Wankhede
      M-pharma Research fellowship (2012-2014) University Grants Commission of India (UGC) Aug 2012 All India rank: 492 in GPAT 2012

  • Volunteer Experience

    • Volunteer

      Issued by Department of Pharmaceutical Sciences R. T. M. Nagpur University, Nagpur on Dec 2013
      Department of Pharmaceutical Sciences R. T. M. Nagpur University, NagpurAssociated with Harshad Wankhede

    • Volunteer

      Issued by Department of Pharmaceutical Sciences R. T. M. Nagpur University, Nagpur on Feb 2014
      Department of Pharmaceutical Sciences R. T. M. Nagpur University, NagpurAssociated with Harshad Wankhede