About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
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.
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