Senior Director, Regulatory Affairs
eGenesisCambridge, Massachusetts, United States
Posted September 25, 2025
Full Time
About the Company
eGenesis is a pioneering company revolutionizing transplantation through advanced gene editing technology. Focused on developing human-compatible organs, tissues, and cells, eGenesis addresses key challenges in xenotransplantation to solve the global organ shortage crisis. The company's mission is to save and improve patients' lives by creating scalable alternatives that overcome existing virology and immunology hurdles.
Job Description
eGenesis is seeking a Senior Director of Regulatory Affairs to lead the development and execution of regulatory strategies for their xenotransplantation programs. This role involves ensuring compliance with FDA and other regulatory agencies, managing consultants, and proactively forecasting regulatory hurdles. The Director will be responsible for planning, submission, and approval of important documents such as INDs and BLAs.
Requirements
- Lead the eGenesis team to create regulatory strategies and successfully manage complex regulatory issues.
- Define regulatory milestones and ensure progress.
- Manage consultants and CROs to support regulatory activities.
- Interact with FDA and other regulatory agencies in the US and globally.
- Participate in and lead regulatory audits and approvals.
- Represent eGenesis at industry and regulatory conferences.
