Nand Kishore Gupta
Senior Manager at Sandoz ׀ Global Regulatory Affairs
- Role
- Senior Manager Global Regulatory Affairs at Sandoz India
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Nand Kishore Gupta
Regulatory Affairs professional with 13+ of experience. core experience in initial filing and Life cycle Management of Solid Orals, Parenteral, and Semisolid for EU/US markets. Submitted quality ANDAs on my creditWell versed with the concept of US-FDA, EMA, Health Canada, and ICH regulations as well as the validation of pharmaceutical products and processes. Fair understanding of Change Control systems. Supported in various international audits i.e. US-FDA, WHO, etc. Hands-on experience in handling of various publishing tools such as ISI (publisher, toolbox) and eCTDXpress, LORENZ validator. Basic understanding of the regulatory requirements for Medical Devices and IVDs.
Experience
Senior Manager Global Regulatory Affairs
Sep 2023 — Present · Hyderabad, IN
Education
Department of Pharmaceutical Sciences, Dr H S Gour University, Sagar
M Pharm, Pharmaceutical Biotechnology
2008 — 2010
Department of Pharmaceutical Sciences, Dr H S Gour University, Sagar
B Pharm, Pharmaceutical Sciences
2004 — 2008
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