Hitendra Singh

Manager- Global Regulatory Affairs CMC at Alvotech Biosciences India Pvt Ltd, Bengaluru, India

Role
Manager Global Regulatory Affairs Cmc at Alvotech
Location
Bengaluru, KA, IN
LinkedIn followers
500 followers

About Hitendra Singh

Regulatory Affairs Professional with ~8.6 years of industrial experience in Biologics…

Experience

  1. Manager Global Regulatory Affairs Cmc

    Alvotech

    Jun 2025 — Present · Bengaluru, IN

    Here I\'m working as Regulatory Affairs CMC Professional in Biosimilars for global regulated and emerging market\'s focusing on Biosimilars CMC regulatory strategies, authoring the CTD sections (Module 3 and Module 2.3) reviewing the quality data for dossier preparation, compilation, submission and publishing for global regulated, emerging markets.

Education

  • LNCT Group of Colleges

    Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences

    2011 — 2015

  • National Institute of Pharmaceutical Education and Research (NIPER) ,SAS NAGAR , Mohali

    Master’s Degree, M.S. (Pharm.) Biotechnology

    2015 — 2017

  • Global Institute of Regulatory Affairs (GIRA) Pune, Maharashtra

    PG Diploma in Regulatory Affairs, Pharmaceutical & Regulatory Science

    2018 — 2019

Skills

  • Pharmaceutical Industry
  • Life Sciences
  • Microsoft Office
  • Microsoft Excel
  • Public Speaking
  • Leadership
  • Management
  • Teamwork
  • Regulatory Affairs
  • Research

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Hitendra Singh — Manager Global Regulatory Affairs Cmc at Alvotech in Bengaluru, KA, IN | Unifers