Review and provide feedback on documents for regulatory submissions in terms of format and compliance in line with regulatory requirements. Compilation and technical quality control of electronic dossiers in docuBridge platform. Provide support and training in Electronic Document Management System (REAL easy). Assist with EDMS system administration and management. Align and agree on work approaches in a team of multiple local and global EDMS admins. Assist with Document Author training. Provide format review of documents for electronic submissions using doc author tool for word and ISI toolbox for pdf format. Assist with Ad Promo documents and maintenance through Veeva system. Compile ad promo submissions through docuBridge platform. Oversee State License applications for manufacturing and wholesale requirements in multiple states.

Responsible for implementing in house eCTD capabilities using docuBridge. Evaluated and implemented internal procedures related to document control, folder structure and electronic archiving. Provided regulatory guidance and submission strategy to clients based on FDA, EMA and ICH regulations. Responsible for submission of eCTD applications via FDA’s electronic gateway. Managed assigned, as well as prepared documents for submissions to regulatory agencies including Annual Reports and PADERS.