I help drug developers communicate with regulatory agencies to receive guidance and gain approval. I also serve as an IRB board member, reviewing protocols that involve human research to ensure that the research is ethical. I work autonomously and across client teams to lead eCTD filings, ensure compliance of electronic submissions, itemize and manage submission components, provide document formatting and publishing services, control document versions, and provide other quality control check functions for regulatory submissions. My focus is primarily on IND applications, but I also support NDA and ANDA filings.