COMPANY MISSION
eGenesis is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering to create safe, effective, and readily available solutions.
POSITION SUMMARY
Reporting to the Senior Vice President of Development and based in our Cambridge, MA office, the Associate Director of Regulatory Affairs is responsible for developing and executing regulatory strategies to ensure that all regulatory requirements and goals are met, from regulatory pathway planning to submission, in accordance with industry standards. The field of xenotransplantation is relatively uncharted and involves a complex relationship between the FDA Center for Veterinary Medicine (CVM) for the transgenic donor animals and Center for Biologics Evaluation and Research (CBER) for the organ product and transplantation to humans.