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.
Experience
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.
