Y.R.Lakshmi

Regulatory Publisher

DXC technologies

11.2021 - Current

Upload finalized documents into the eCTD submission manager to create a final submission copy
Ensured compliance with company policies related to quality assurance processes during production cycles.
Analyzed clinical trial data sets for comparability between different regions or countries.
Compiled data from multiple sources into well-structured tables that could be used for reporting purposes.
Assisted with the preparation of periodic reports summarizing market dynamics within a given therapeutic area.
Coordinated with international regulators regarding submissions, reviews, approvals, queries and other matters.
Conducted research on current industry trends and best practices in order to stay abreast of changes in the field.
Developed templates for standard operating procedures related to regulatory publishing operations.
Compile and review quality assessments and vendor qualification for vendors
Trained to use Veeva Vault RIIM, Import and Report submissions to FDA
Researched global standards for submission formats across various regions and countries.
Monitored industry news related to developments in FDA regulations or guidelines impacting pharmaceuticals products.
Only team member to get trained by External source
Review technical documents required for submissions and ensure compliance with applicable regulations and guidance
Reviewing of standard regulatory documents i.e., Summary documents, Clinical protocols etc
Review, publish, compile and QC all sections of aggregate reports such as global regulatory submissions
Manage and control all submission dossiers and related documents in accordance with and regulatory guidelines
Develop and maintain SOPs as required to assure consistency and compliance
Prepared regulatory submissions Including authoring, reviewing, which were in accordance with FDA Regulations
Responsible for the authoring of annual reports, periodicals and annual reports with minimal supervision in accordance with regulations
Trained other associates on eCTD submissions to condense content to regulation for electronic submission
Ensured that hard copy documents are appropriately rendered into guidance for electronic submissions
Provided In-depth knowledge and experience with Adobe Acrobat, MS Word
Managing electronic regulatory media and preparing electronic submissions
Worked on Annual Reports, Investigator brochures, Clinical Reports, All sections of eCTD.