Deepika Maganti Email & Phone Number | -Manage, author and review Technical/CMC Regulatory submissions for US and global submissions for MAbs, combination Biologic/Device products. -Work with cross functional teams for document preparation and strategy for new submissions, supplements and Agency requests. Spearheaded ANDA projects from beginning to end. Collaborated with manufacturing sites, publishing teams and ensure timely submission of original ANDAs . • Developed strategies and author CMC sections for ANDAs, CRLs, key amendments and supplements. • Prepared, reviewed and finalized ANDA write up documents related to Module 1 through Module 5 which include technical write up of CMC section impurity profiles, justification of specifications. Work with a team of Regulatory analysts by providing oversight and guidance on preparation, QC, formatting and publishing of documents and ensure Submission Readiness, pre/post publishing QC of IND/NDA and MAA submissions, and NDA supplements, Day 80 and Day 120 responses of MAA to comply with current eCTD guidance document. • Reviewed core data sheet and assist in labeling updates. • Prepared post marketing Advertising Promotional materials for agency’s approval. • Worked with CMC team to prepare and QC responses and provide cross functional support.Led cross-functional team meetings in preparation of drug applications to identify availability of source documentation as well as to identify the overall timeline for submission. • Implemented strategy and created process flow to align R&D team and CMO’s to fit into time line for timely submission. • Prepared, reviewed and compiled Regulatory documents for global regulatory filings for small molecules in eCTD format through global submit meeting FDA requirements. • Created Module 1, 2, 3 and 5 including study tagging and preparing clinical summaries, CMC section and Quality Overall Summary (QOS) for small molecules.

Deepika Maganti

-Manage, author and review Technical/CMC Regulatory submissions for US and global submissions for MA...
New York, New York, United States

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Deepika Maganti’s Email deepika.maganti@tevapharm.com

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Deepika Maganti’s Location New York, New York, United States

Deepika Maganti’s Current Industry GSK US

Deepika Maganti’s Prior Industry Teva Pharmaceuticals | Durata Therapeutics | RiconPharma LLC

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Work Experience

GSK US

Regulatory Affairs Manager (CMC)

2018-02-01 00:00:00 - Present

Teva Pharmaceuticals

Sr.Regulatory Affairs Associate

2015-08-01 00:00:00 - 2018-02-01 00:00:00

Durata Therapeutics

Regulatory submission specialist (contractor)

2014-06-01 00:00:00 - 2015-06-01 00:00:00

RiconPharma LLC

Sr Regulatory Scientist

2011-02-01 00:00:00 - 2014-06-01 00:00:00

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FAQ About Deepika Maganti

Deepika Maganti is located at
New York, New York, United States

Deepika Maganti is a -Manage, author and review Technical/CMC Regulatory submissions for US and global submissions for MAbs, combination Biologic/Device products. -Work with cross functional teams for document preparation and strategy for new submissions, supplements and Agency requests. Spearheaded ANDA projects from beginning to end. Collaborated with manufacturing sites, publishing teams and ensure timely submission of original ANDAs . • Developed strategies and author CMC sections for ANDAs, CRLs, key amendments and supplements. • Prepared, reviewed and finalized ANDA write up documents related to Module 1 through Module 5 which include technical write up of CMC section impurity profiles, justification of specifications. Work with a team of Regulatory analysts by providing oversight and guidance on preparation, QC, formatting and publishing of documents and ensure Submission Readiness, pre/post publishing QC of IND/NDA and MAA submissions, and NDA supplements, Day 80 and Day 120 responses of MAA to comply with current eCTD guidance document. • Reviewed core data sheet and assist in labeling updates. • Prepared post marketing Advertising Promotional materials for agency’s approval. • Worked with CMC team to prepare and QC responses and provide cross functional support.Led cross-functional team meetings in preparation of drug applications to identify availability of source documentation as well as to identify the overall timeline for submission. • Implemented strategy and created process flow to align R&D team and CMO’s to fit into time line for timely submission. • Prepared, reviewed and compiled Regulatory documents for global regulatory filings for small molecules in eCTD format through global submit meeting FDA requirements. • Created Module 1, 2, 3 and 5 including study tagging and preparing clinical summaries, CMC section and Quality Overall Summary (QOS) for small molecules.