Skills

• Preparation and submission of eCTD filing of formulation dossiers for US, Europe.
• Compilation and validation of electronic regulatory submissions in accordance to US, EU and domestic regulatory bodies including State FDA, DCGI etc.
• Worked on validation of eCTD submission through Lorenz, EURS/Global and Insight validator software
• Perform Datavision searches to locate original disclosures and other resources (journal sites like Pub-med, Research gate, Elsevier etc.) where necessary
• Worked on Pre-Publishing activities i.e., Doc-Prep with ISI tool box and Smart Desktools.
• Worked on complete eCTD preparation with eCTD express and Insight publisher software.
• Resolving validation related and publishing related errors/issues
• Fluent in English with excellent writing and good communication skills.
• Led successfully a team of 10 to complete two projects and got appreciation from the firm.
• Excellent basic computer skills in MS office, MS Excel, and SharePoint applications and data base.

Refrences

Pharmacovigilance - EVPRM creation, IDMP

Regulatory Publishing - eCTD publishing and validation

USFDA Annual Report Preparation

Clinical document formatting, document level publishing

Clinical doument redaction

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