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Munendra Kumar is listed as Vice President - Global Regulatory Affairs at Glenmark Pharmaceuticals at Glenmark Pharmaceuticals, based in India, India, India. AeroLeads shows a work email signal at glenmarkpharma.com and a matched LinkedIn profile for Munendra Kumar.
Munendra Kumar previously worked as Vice President - Global Regulatory Affairs at Glenmark Pharmaceuticals and Global Head (Director) - Regulatory Affairs at Imedglobal Corporation. Munendra Kumar holds M.Pharmacy, Pharmaceutics from Rajiv Gandhi University Of Health Sciences.
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AeroLeads found 1 current-domain work email signal for Munendra Kumar. Compare company email patterns before reaching out.
Result-driven, regulatory affairs professional with continuous advancement and expertise in Development products (NCEs), Marketed brands (NDA/MAA), Generics (ANDA/EU Article 10.1, 10.3, 10a, 10b,10c) etc.Regulatory Submission MRP, CP, DCP, Parallel DCP, Duplicate Licencing, NDA, ANDA etc Technical Operations/Technical Research and Development/ Global or Country specific regulatory requirements/guidance.Skilled Regulatory Professional with rich experience in Project Management and Global Regulatory Strategies (US, EU and ROW).Change Control Management system for EU and USSpecialties: Direct interaction with EU Health Authority (MHRA, MPA, MEB etc)Global Regulatory Strategies CMC and Clinical (US, EU and ROW).Liaison Manager (Project Management).Post Approval Submissions in EU and US.Six-Sigma Certified Professional.Aspirational and Effetive Leadership Skills.OTC, Cosmetic, Medical Devices.eCTD Publication, SPL etc.OTC/Medical device/Cosmetic products
Listed skills include Regulatory Affairs, Ectd, Six Sigma, Anda, and 20 others.
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A career timeline built from the work history available for this profile.
Mumbai, Maharashtra, IN
Regulatory strategy for Global dossier (CMC)submissions across US/EU/ROW regions. ANDAs/NDA submissions to USFDA.Regulatory Submissions, CMC (CTD/ Regional specific) to EU regions and other Regions of world (ROW).Ensuring DCP/MRP/ National application approval as per agreed business timelines.Global Labelling Management for Generic/ Innovator Product.
Fort Washington, Pennsylvania, US
1. Created Regulatory team for EMEA, US and APAC region for delivering projects for Top 3 Pharmaceutical and consumer health organization, OTC product portfolio.2. Managing technical team (150 RESOURCES) of qualified people for on-time delivery of Regulatory Projects across EU, US and APAC region for Top 3 Pharmaceutical and consumer health organization.3..
Stockholm, SE
1.Managing technical team of qualified people (employees & consultants) and coordinating activities (DCP, MRP, Repeat use MRP, Parallel DCP, CMC Variation, Clinical and Labelling Variation and EU Renewal) for maximizing the value of company portfolio.2. Improve work processes at define levels of the company for effective resource management and Budget.
Basel, Baselstadt, CH
Development products (NCEs), Marketed brands (NDA/MAA), Generics (ANDA/EU Submission via MRP, CP and DCP) and Technical Operations/Technical Research and Development/ Global or Country specific regulatory requirements/guidance.NDA Submission, CBE 30, PAS Submission, Annual Report for NDAs.CP/MRP submission for MAA in EU, Renewal and Variation.
Technical CMC documentation in CTD/NTA formats for Generic drug product registration in the US and European Union.Drug product registration in the European Union via National, MRP and DCP procedures.Compilation and submission of complete dossier (Module 1, 2, 3 and 5) for US ANDA.Complete compilation, validation and publishing of ANDA in eCTD.
Other employees you can reach at drugs.com. View company contacts →
Chandra Frazier
Colleague at Glenmark Pharmaceuticals
New York City Metropolitan Area, United States, United States
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Angshuman Gogoi
Colleague at Glenmark Pharmaceuticals
Mumbai, Maharashtra, India, India
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Saifur Rahman
Colleague at Glenmark Pharmaceuticals
Mumbai Metropolitan Region, India, India
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Diplaxmi Sonawane
Colleague at Glenmark Pharmaceuticals
India, India
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Sambit Sathapathy
Colleague at Glenmark Pharmaceuticals
Mumbai, Maharashtra, India, India
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Gaurav Karkhanis
Colleague at Glenmark Pharmaceuticals
Mumbai, Maharashtra, India, India
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HM
Harsh Mehta
Colleague at Glenmark Pharmaceuticals
Mumbai, Maharashtra, India, India
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KD
Khushbu Desai
Colleague at Glenmark Pharmaceuticals
Mumbai, Maharashtra, India, India
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L(
Liang (Leon) Huang
Colleague at Glenmark Pharmaceuticals
Springfield, New Jersey, United States, United States
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AC
Alex Craig
Colleague at Glenmark Pharmaceuticals
Lancaster, South Carolina, United States, United States
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Quick answers generated from the profile data available on this page.
Munendra Kumar works for Glenmark Pharmaceuticals.
Munendra Kumar is listed as Vice President - Global Regulatory Affairs at Glenmark Pharmaceuticals at Glenmark Pharmaceuticals.
AeroLeads has found 1 work email signal at @glenmarkpharma.com for Munendra Kumar at Glenmark Pharmaceuticals.
Munendra Kumar is based in India, India, India while working with Glenmark Pharmaceuticals.
Munendra Kumar has worked for Glenmark Pharmaceuticals, Imedglobal Corporation, Bluefish Pharmaceuticals, Novartis, and Alembic Pharmaceutical Private Limited.
Munendra Kumar's colleagues at Glenmark Pharmaceuticals include Chandra Frazier, Angshuman Gogoi, Saifur Rahman, Diplaxmi Sonawane, and Sambit Sathapathy.
You can use AeroLeads to view verified contact signals for Munendra Kumar at Glenmark Pharmaceuticals, including work email, phone, and LinkedIn data when available.
Munendra Kumar holds M.Pharmacy, Pharmaceutics from Rajiv Gandhi University Of Health Sciences.
Munendra Kumar is listed with skills including Regulatory Affairs, Ectd, Six Sigma, Anda, Pharmaceuticals, Mrp, Dcp, and Nda.
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