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
Manager Global Regulatory Affairs Cmc
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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