Mahesh Nayakula
Currently, working as a Senior Manager Regulatory Life cycle management for Biosimilar products and responsible for regulatory change... | Bengaluru, Karnataka, India
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Mahesh Nayakula’s Emails ma****@bi****.com
Mahesh Nayakula’s Phone Numbers No phone number available.
Social Media
Mahesh Nayakula’s Location Bengaluru, Karnataka, India
Mahesh Nayakula’s Expertise Currently, working as a Senior Manager Regulatory Life cycle management for Biosimilar products and responsible for regulatory change assessment, Regulatory strategy, CMC authoring, Renewals submission, and Annual reports submission. Responsible for submission of applications for Marketing Authorization for Novel Biologics/Biosimilars to the regulatory authority Responsible for submission of application to conduct clinical trials with Novel Biologics/Biosimilars to the regulatory authority. CMC documents related to the Biologics/ Biosimilars preparation as per CTD, review and compilation in Module 3 Review, preparation and submission of documents related to Variations/Post approval changes for Biological products to the regulatory authority Global clinical trial protocol review and submission to the regulatory authority for Biosimilars/Biologics
Mahesh Nayakula’s Current Industry Alvotech
Mahesh
Nayakula’s Prior Industry
Biocon
|
Imedglobal
|
Pfizer
|
Merck
|
Oxford Global Resources
|
Alvotech
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Work Experience
Alvotech
Senior Manager Global Regulatory Affairs
Mon Jan 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Oxford Global Resources
Senior Manager - Global Regulatory Affairs (Consultant)
Sun Jan 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Senior Specialist (Expert 2)
Sat Aug 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Pfizer
Regulatory Affairs Senior Executive
Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Aug 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Imedglobal
Regulatory Affairs Executive
Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Biocon
Regulatory Affairs Executive
Tue Jul 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Mahesh Nayakula Email Addresses
FAQ About Mahesh Nayakula
-
Mahesh Nayakula is located at
Bengaluru, Karnataka, India -
Mahesh Nayakula is a
Currently, working as a Senior Manager Regulatory Life cycle management for Biosimilar products and responsible for regulatory change assessment, Regulatory strategy, CMC authoring, Renewals submission, and Annual reports submission. Responsible for submission of applications for Marketing Authorization for Novel Biologics/Biosimilars to the regulatory authority Responsible for submission of application to conduct clinical trials with Novel Biologics/Biosimilars to the regulatory authority. CMC documents related to the Biologics/ Biosimilars preparation as per CTD, review and compilation in Module 3 Review, preparation and submission of documents related to Variations/Post approval changes for Biological products to the regulatory authority Global clinical trial protocol review and submission to the regulatory authority for Biosimilars/Biologics Alvotech -
Mahesh Nayakula currently works in the
Alvotech -
Mahesh Nayakula specializes in
Currently, working as a Senior Manager Regulatory Life cycle management for Biosimilar products and responsible for regulatory change assessment, Regulatory strategy, CMC authoring, Renewals submission, and Annual reports submission. Responsible for submission of applications for Marketing Authorization for Novel Biologics/Biosimilars to the regulatory authority Responsible for submission of application to conduct clinical trials with Novel Biologics/Biosimilars to the regulatory authority. CMC documents related to the Biologics/ Biosimilars preparation as per CTD, review and compilation in Module 3 Review, preparation and submission of documents related to Variations/Post approval changes for Biological products to the regulatory authority Global clinical trial protocol review and submission to the regulatory authority for Biosimilars/Biologics -
Mahesh Nayakula speaks the following languages:
No languages available. -
Mahesh Nayakula has prior experience in the following industries:
Oxford Global Resources , Merck , Pfizer , Imedglobal , Biocon -
Mahesh Nayakula has the following professional experience:
Alvotech , Oxford Global Resources , Merck , Pfizer , Imedglobal , Biocon . -
You can view Mahesh Nayakula’s
LinkedIn profile at LinkedIn URL. -
Mahesh Nayakula’s work email addresses are
[email protected] . -
Mahesh Nayakula works at
Alvotech
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