Gauri Shinde
Working with Genpact in Regulatory Affairs CMC. Handling PLCM activities for EU, Canada, US and RoW markets Worked with... | Mumbai, Mumbai, India
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Gauri Shinde’s Emails ga****@ci****.com
Gauri Shinde’s Phone Numbers No phone number available.
Social Media
Gauri Shinde’s Location Mumbai, Mumbai, India
Gauri Shinde’s Expertise Working with Genpact in Regulatory Affairs CMC. Handling PLCM activities for EU, Canada, US and RoW markets Worked with Apotex, ADVANZ Pharma, Cipla Ltd., J.B.Chemicals and Pharmaceuticals Ltd. in Regulatory Affairs. Key responsibilities - Product life cycle management. Variations submissions, RFI response, Annual report submission, MA Transfer, Tech-Transfers, Site registration, Renewal submissions. Evaluation of CMC changes, supplier driven changes. System/Software/Database handling - Veeva, Trackwise, RIMS, Docubridge, EQMS, GLAMs, MyQUMAS, NOVOS, Sarjen, DMS.
Gauri Shinde’s Current Industry Genpact
Gauri
Shinde’s Prior Industry
Reliance
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Haffkine Institute For Research Training And Testing
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Gebbs Healthcare Solutions
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Cipla
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Jb
|
Advanz Pharma
|
Apotex
|
Genpact
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Work Experience
Genpact
Lead Associate Regulatory Affairs
Wed Dec 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Apotex
Global Regulatory Affairs Senior Analyst
Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Nov 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Advanz Pharma
Regulatory Affairs Executive
Sat Sep 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Jb
Regulatory Affairs Officer
Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Cipla
Regulatory Affairs Research Associate
Thu Oct 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Oct 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Gebbs Healthcare Solutions
Medical Coder
Wed Oct 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Haffkine Institute For Research Training And Testing
Research Intern
Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jun 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Reliance
Research Trainee
Thu Dec 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Gauri Shinde Email Addresses
FAQ About Gauri Shinde
-
Gauri Shinde is located at
Mumbai, Mumbai, India -
Gauri Shinde is a
Working with Genpact in Regulatory Affairs CMC. Handling PLCM activities for EU, Canada, US and RoW markets Worked with Apotex, ADVANZ Pharma, Cipla Ltd., J.B.Chemicals and Pharmaceuticals Ltd. in Regulatory Affairs. Key responsibilities - Product life cycle management. Variations submissions, RFI response, Annual report submission, MA Transfer, Tech-Transfers, Site registration, Renewal submissions. Evaluation of CMC changes, supplier driven changes. System/Software/Database handling - Veeva, Trackwise, RIMS, Docubridge, EQMS, GLAMs, MyQUMAS, NOVOS, Sarjen, DMS. Genpact -
Gauri Shinde currently works in the
Genpact -
Gauri Shinde specializes in
Working with Genpact in Regulatory Affairs CMC. Handling PLCM activities for EU, Canada, US and RoW markets Worked with Apotex, ADVANZ Pharma, Cipla Ltd., J.B.Chemicals and Pharmaceuticals Ltd. in Regulatory Affairs. Key responsibilities - Product life cycle management. Variations submissions, RFI response, Annual report submission, MA Transfer, Tech-Transfers, Site registration, Renewal submissions. Evaluation of CMC changes, supplier driven changes. System/Software/Database handling - Veeva, Trackwise, RIMS, Docubridge, EQMS, GLAMs, MyQUMAS, NOVOS, Sarjen, DMS. -
Gauri Shinde speaks the following languages:
No languages available. -
Gauri Shinde has prior experience in the following industries:
Apotex , Advanz Pharma , Jb , Cipla , Gebbs Healthcare Solutions , Haffkine Institute For Research Training And Testing , Reliance -
Gauri Shinde has the following professional experience:
Genpact , Apotex , Advanz Pharma , Jb , Cipla , Gebbs Healthcare Solutions , Haffkine Institute For Research Training And Testing , Reliance . -
You can view Gauri Shinde’s
LinkedIn profile at LinkedIn URL. -
Gauri Shinde’s work email addresses are
[email protected] . -
Gauri Shinde works at
Genpact
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