Shalu Kumar
Senior Executive-regulatory Affairs at Teva Pharmaceuticals
Based in Mumbai, India
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Seniority
Manager
Department
General Business & Management
Location
Mumbai
Industry
Pharmaceutical Manufacturing
Company size
30K
Contact information
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s•••••••@tevapharm.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Shalu Kumar
Regulatory Affairs professional with 7 years of experience specializing in post-approval CMC submissions and original ANDA/NDA filings for global markets. Currently handling Europe post-approval variations (MRP/DCP procedures) at Teva Pharmaceuticals, ensuring seamless regulatory compliance and timely approvals. Previously, at Viatris (Mylan Laboratories Ltd.), I managed US, WHO, and PEPFAR markets, leading original ANDA/NDA submissions, ECD/IR/CRL responses, and regulatory strategy development. Key Expertise: CMC Documentation & Compliance Post-Approval Variations (EU, US, WHO, PEPFAR) ANDA/NDA Filings & Lifecycle Management Global Regulatory Guidelines (ICH, EMA, USFDA, etc.) Cross-Functional Collaboration & Problem-Solving I hold a Master’s in Pharmacology from GGV Central University, Bilaspur and am passionate about driving regulatory excellence in the pharmaceutical industry.
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