Stephanie brings over 20 years of regulatory operations experience in the pharmaceutical and medical device industries, having worked for both large pharmaceutical companies and CROs. She has spent most of her career preparing documents and eCTD submissions for dispatch to various Health Authorities in addition to maintaining document templates and staying up to date on various Health Authority guidance's for electronic submissions. She has supported a variety of applications including INDs, NDAs/BLAs,and MAAs throughout their lifecycle from kickoff to post-approval activities including several complex NDA applications. Stephanie also has experience managing a high-volume publishing team, which supported several application types for various Health Authorities. Stephanie has a BS in Psychology from Eastern Michigan University.