Deepika M. Email & Phone Number

United States

Pennsylvania

-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… Show more 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. Show less

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… Show more 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. Show less