Mitali Thakore

• Over 5 years of experience working in the pharmaceutical industry.
• Over 3.5years of experience working for ICON Clinical Research.
• Hands-on experience in handling and publishing of electronic andpaper-based regulatory documents.
• Profound knowledge of regulatory publishing standards andprocedures.
• Languages: English, Hindi, Gujarati.
• Experience handling technical applications and the basicunderstanding of computer systems, exposure to pharmaceutical industrial environment of facing audits andinspections.
• Strong communication; project and time management skills.
• Worked well under pressure as a leader and in teams on variousRAprojects; open minded personality with a positive attitude.
• Powerful organizational, negotiation and analytical skills with theability to assess scientific data.

• Created and implemented effective publishing and formattingstandards for regulatory submissions.
• Formatted, published, and submitted all assigned regulatorydocuments, on time.
• Organized, bookmarked, hyperlinked, monitored, and maintained allregulatory files for submission.
• Checked, validated and tracked all regulatory documents forcorrectness and completeness.
• Experience in Regulatory Publishing using Extedo-eCTDManager, Adobe Acrobat Professional, Lorenz Validator and various other toolbox.
• Publishing activities included formatting, proofreading and correction of typographical and grammatical errors, insertion of appendix pieces into documents, scanning, clean-up of PDF files, QC of each publishing step as well as published product.
• Documents and dossiers for submission to clients and regulatoryauthorities, compilation, printing, print QC, page numbering, tabcreation, assembly/binding, label creation and application.
• Packing for shipment to clients and/or regulatory authorities.
• Accomplishing expertise in all stages of drug lifecyclemanagement.
• Experience in strategy implementation of different submissionmanagement like CTAs, INDs, NDAs, ANDAs, BLAs, DMFs, etc.

Regulatory Affairs

Humber College • Toronto, Ontario

12/2017

Bachelor of Science (Pharmacy)

Rajiv Gandhi University • Mangalore, Karnataka

04/2009