Ms. Hansen has been involved in the development and regulatory management of product programs within the pharmaceutical and bioscience industries for over 30 years. Her experience spans the drug development lifecycle starting in product development and research and continuing through to commercial launch and post market monitoring for solid dose, parenteral and combination products. She has held leadership positions in both large Pharma and virtual start-up organizations where she has successfully overseen the regulatory submission and maintenance programs for multiple products. Ms. Hansen’s expertise includes CMC , clinical and non-clinical modules and extends to both US and global regulatory filings that utilize the eCTD format. She is an active member of the Regulatory Affairs Professional Society (RAPS) certification program and currently sits on the RACB (Regulatory Affairs Certification Board).