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Shakun Kumar Location
Mumbai, MH, IN
Shakun Kumar Work
2025 -now Director Regulatory Affairs @
2020 -2025 Head Regulatory Affairs US,CA,ANZ,ROW @
2016 -2020 Director Regulatory Affairs @ Sinotherapeutics Inc.
2014 -2016 Associate Director @ Sinotherapeutics Inc.
2013 -2014 Regulatory Affairs Manager @
2010 -2013 Research Scientist Regulatory Affairs @
2008 -2010 Research Associate Regulatory Affairs @
Shakun Kumar Education
Welingkar Institute of Management
PGDBM (International Business)
2018-2020
Hindu College of Pharmacy
Bachelor of Pharmacy (B.Pharm.) (Pharmaceutical Sciences)
Punjabi University
Shakun Kumar Skills
Regulatory Submissions
ANDA
Regulatory Requirements
eCTD
Generic Programming
Research
Dissolution
Pharmaceutical Industry
Global Regulatory Affairs
Global Regulatory Compliance
Business Enabler
Regulatory Strategy Development
TrackWise
Life Cycle Cost Analysis
Quality Management System
Regulatory Budgeting
Product Lifecycle Management
Regulatory Affairs
GMP
Validation
Pharmacovigilance
Abbreviated New Drug Application (ANDA)
Clinical Trials
FDA
Electronic Common Technical Document (eCTD)
Technology Transfer
Quality System
U.S. Food and Drug Administration (FDA)
Sales
Microsoft Office
Customer Service
Science
Abbreviated New Drug Application Anda
u.s. Food and Drug Administration Fda
Electronic Common Technical Document Ectd
Abbreviated New Drug Application
Electronic Common Technical Document
u.s. Food and Drug Administration
Shakun Kumar Summary
Shakun Kumar, based in Mumbai, MH, IN, is currently a Director Regulatory Affairs at ADVANZ PHARMA. Shakun Kumar brings experience from previous roles at ADVANZ PHARMA, Sinotherapeutics Inc. and MACLEODS PHARMACEUTICALS LTD.. Shakun Kumar holds a 2018 - 2020 PGDBM in International Business @ Welingkar Institute of Management. With a robust skill set that includes Regulatory Submissions, ANDA, Regulatory Requirements, eCTD, Generic Programming and more. Shakun Kumar has 2 emails and 4 mobile phone numbers on RocketReach.
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