Kushal Pagare
Regulatory Affairs Associate @Parexel
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WORK HISTORY
Regulatory Affairs Associate @Parexel
Bengaluru, IN
Experienced in eCTD Publishing and Post Publishing QC (IND, NDA, EU, Swiss etc.) to ensure the quality of eCTD submissions and the documents involved, along with document preparation, legacy. conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, pagination, and formatting of reports and other submissions. Experienced in IND, NDA, DSUR, Annual Reports and Amendment Submissions. Creating Lifecycle Submissions as per submission planners provided by the clients. Publishing Activities – Sequence building as per the planner, assigning documents, publishing of eCTD, Dispatch of the eCTD via Electronic Submission Gateways of USFDA and Europe Agencies.CMC Co-ordination -• Coordination of CMC activities for all projects in charge• Contact affiliates Worldwide and manufacturing sites (France & Canada)• Build Regulatory strategy assessment for variations based on affiliates information• Update Documentum database (D2)• Project managementData Management Activity - • Data Management: running project Master Tracker, post tracker run activities, KPIs, QC checks, etc.• post-approval variation (Marketing Authorization Transfer) progress tracking in Veeva RIM ofCHC products for Gulf, Africa and Europe countries. Updating Veeva Vault with submission date,approval date and other necessary details such as MAH change within the given timeline andupdating the SRFTechnical Expertise: Publishing: InSight Publisher, Lorenz docuBridge, eCTD Manager (extedo) Proficient in using Adobe Acrobat, Liquent SmartDesk for PDF, ISI Toolbox. Amazon Work space. Document Management Systems: SharePoint, Veeva Vault, FirstDoc, and WorkZone Technical Validators: Insight Validator, Lorenz eValidator, EURSvalidator and Global Validator.
EDUCATION
University of Mumbai
Bachelor of Pharmacy - BPharm
ABOUT KUSHAL PAGARE
Results-driven regulatory affairs expert with 5 years of experience ensuring compliance with global regulatory requirements. Proven track record of successfully navigating complex regulatory landscapes, managing cross-functional teams, and driving business growth. Skilled in regulatory strategy, submissions, and product lifecycle management. Passionate about delivering high-quality products that meet the needs of patients and healthcare professionals.
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