Kristin Katzberg

Kristin Katzberg has extensive work experience in regulatory operations and submissions in the biopharmaceutical and medical device industries. Kristin currently serves as the Director of Regulatory Planning and Operations at Altimmune, Inc., where they are responsible for coordinating and managing eCTD and non-eCTD submissions to health authorities. Kristin is also adept at implementing regulatory information management systems.

Prior to their current role, Katzberg held positions at Athersys, where they served as the Director of Global Regulatory Operations and Senior Manager of Global Regulatory Operations. In these roles, they oversaw cross-functional teams and provided guidance on worldwide health authority submissions and requirements.

Katzberg also gained experience in regulatory submissions operations at Cardinal Health, where they served as a Manager, Supervisor, and Specialist I. Kristin worked on document management for electronic Common Technical Documents (eCTDs) and nonCTDs for submission to the Food and Drug Administration (FDA) for approval.

Before entering the biopharmaceutical industry, Katzberg worked as a Pathologists' Assistant at Physicians Reference Laboratory, where they performed various responsibilities related to human surgical/oncology tissue specimens. Kristin also gained experience in sales coordination at Ford Hospitality Services and worked as a Laboratory Technician at Dalton Research Facility.

Overall, Katzberg's work experience demonstrates their expertise in regulatory operations, submissions, and project management in the healthcare and pharmaceutical sectors.

Kristin Katzberg holds a Bachelor of Health Science degree in Health/Health Care Administration/Management from the University of Missouri-Columbia, which they obtained from 2009 to 2012. Kristin also pursued a Biology degree from the University of Maryland from 1996 to 1999, although no specific degree name was provided. In terms of additional certifications, Kristin Katzberg is a member of the Regulatory Affairs Professionals Society (RAPS) since January 2023. Kristin also holds a SHP Health Literacy Certificate from the University of Missouri-Columbia, although the exact dates of obtaining this certificate were not provided.