Senior Director, Regulatory Affairs

eGenesis
Cambridge, MA
Category Consulting
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.
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