Shalu Kumar
Senior Regulatory Affairs Professional | CMC | Post-Approval & Original Submissions | EU, US, WHO, PEPFAR | Teva | Ex-Viatris (Mylan)
- Role
- Senior Executive-regulatory Affairs at Teva Pharmaceuticals
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Shalu Kumar
Regulatory Affairs professional with 7.5 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-SolvingI hold a Master’s in Pharmacology from GGV Central University, Bilaspur and am passionate about driving regulatory excellence in the pharmaceutical industry.
Experience
Senior Executive-regulatory Affairs
Jul 2021 — Present · IN
Acted as regulatory lead for assigned EU product portfolio, overseeing lifecycle compliance and ensuring timely submissions.• Provided regulatory risk assessments for EU variations and renewals to ensure compliance with evolving EMA guidelines.• Communicated regulatory strategies and potential risks to senior RA management, aligning execution with corporate objectives.• Managed >30 EU renewals and 100+ post-approval variations (Quality, Safety, Administrative) under MRP/DCP, ensuring 100% on-time submissions.• Implemented Worksharing and Supergrouping procedures, reducing duplication and improving efficiency of submissions.• Maintained lifecycle documentation by updating GRIDS/GI, ensuring data integrity and audit readiness.• Collaborated cross-functionally with QA, RA, and European agencies to streamline submissions and resolve queries.• Trained in EMA PLM portal form filling for variation submissions, ensuring accuracy and EU compliance.
Education
Sardar Bhagwan Singh (PG) Institute of Bio-Medical Sciences & Research
Bachelor of Pharmacy - BPharm
2011 — 2015
Guru Ghasidas University
M.PHARMACY, Pharmacology
2015 — 2017
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