Avisek M
Global Regulatory Affairs-senior Professional @Novo Nordisk
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WORK HISTORY
Global Regulatory Affairs-senior Professional @Novo Nordisk
Handling New marketing authorization and post approval variations, eCTD, dossier preparation, review, Compilation & submission to HA, Core dossiers, variations, renewals, EU, UK, US, CA, CH, LATAM, Japan, APAC, AU, NZ. Stakeholder management, Project Management. Handling life cycle management within EU (variation: Type IA, IAIN, IB, II, extension, renewal etc) & US (PAS, CBE-30, CBE-0, AR).Expert in handling EU submission processes CP, MRP, DCP, NP.
EDUCATION
Birla Institute of Technology Mesra
Masters Degree, Mpharm
ABOUT AVISEK M
Seeking to resume my career in Regulatory Affairs Area
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