Olivia Draffkorn
Regulatory Publication Analyst
Olivia Draffkorn serves as a Regulatory Analyst for Pearl Pathways. She supports putting the finishing touches on submission files so that they meet regulatory agency requirements. Olivia uses eCTD software to assemble regulatory filings based on the eCTD table of contents, adds the appropriate metadata and hyperlinks, and compiles submissions for electronic delivery to regulatory agencies. Olivia is experienced with publishing IND, NDA and ANDA filings, annual reports, amendments, safety reports, and meeting requests.
Olivia has over five years of writing and editing experience from her background in both quality assurance and regulatory affairs and is capable of managing multiple assignments, timelines, and budgets. This experience enables Olivia to leverage strong project management skills to prepare submissions, understand client needs and agency expectations, and format complex documents. Olivia earned a BS in Biological Sciences from University of Illinois at Chicago.