sr manager - global regulatory affairs at elanco ii ex-lilly ii ex-novartis ii project managment ii gmp ii labelling ii cmc@ Elanco
Bengaluru, Karnataka, India
Venugopal Malpani
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FlashIntel GPTVenugopal Malpani is an experienced Regulatory Affairs Professional with 8 years of experience in Global Regulatory Submissions across various regions. He has a strong understanding of the Pharmaceutical domain and has worked with countries like the USA, Europe, and Asian countries. Venugopal has extensive knowledge of submissions and ICH requirements to various countries. He specializes in Global Regulatory Affairs, Project Management, and International Business Development. With a diverse work experience, including senior associate management positions at Eli Lilly and Company, Novartis, Synowledge LLC, Apotex Inc., Medreich Limited, and GE.
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About
Experienced Regulatory Affairs Professional with 8 years of experience in Global Regulatory submissions across different regions like US, EU, CDN & AUS and ROW countries for Orals, liquids, Injectable & food supplements dosage forms at different levels (local, regional & global). Keen insight and understanding of the Pharmaceutical domain, with in-depth understanding of submissions and ICH requirements to various countries like USA, Europe, and Asian countries, Australia, CIS countries, Singapore, South Africa (MCC). Specialties: Regulatory Affairs Areas of Interest: Global Regulatory affairs, Project Management & International Business Development.
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sr manager - global regulatory affairs at elanco ii ex-lilly ii ex-novartis ii project managment ii gmp ii labelling ii cmc
Pharmaceutical Manufacturing
Venugopal Malpani's Professional Milestones
- Associate Manager Ii, Global Regulatory (2015-02-01~2017-06-01): Implementing successful global regulatory strategies to ensure compliance and enhance overall business performance.
- Team Lead (2014-04-01~2015-02-01): Achieved mastery in the field, driving team efficiency and delivering exceptional results.
Skill
Regulatory Affairs
Ectd
Quality Assurance
Regulatory Submissions
Anda
R&d
Generic Programming
Pharmaceutical Industry
Regulatory Requirements
Sop
Gmp
Pharmaceutics
Fda
Glp
Change Control
Global Regulatory Compliance
Abbreviated New Drug Application
Standard Operating Procedure
Electronic Common Technical Document
Certification
Colleagues
Dusti Bailey
Product Owner
Guus ter Haar
Product Owner | Scrum & Agile Certified
Pascal Houtin
Process Owner Director
Andrew Elliott
Digital Product Manager | Product Life Cycle Manager | Digital Application Support | Product Owner
Nick Davis
global process owner - order to cash at elanco
Other Named Venugopal Malpani
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Venugopal Malpani works for Elanco
Venugopal Malpani's role in Elanco is sr manager - global regulatory affairs at elanco ii ex-lilly ii ex-novartis ii project managment ii gmp ii labelling ii cmc
Venugopal Malpani works in the industry of Pharmaceutical Manufacturing
Venugopal Malpani's colleagues are Dusti Bailey,Guus ter Haar,Pascal Houtin
Venugopal Malpani's latest job experience is sr manager - global regulatory affairs at elanco ii ex-lilly ii ex-novartis ii project managment ii gmp ii labelling ii cmc at Elanco
