eGenesis, Inc.

Compliance

• Lead the eGenesis team to create regulatory strategies for each transplant organ program and successfully manage complex issues which have significant impact on the business
• Lead definition of regulatory milestones and ensure that the company remains on track to support achievement of those milestones
• Lead and manage consultants and CROs who are charged to support regulatory activities
• Manage all activities pertaining to interactions and communications with FDA and other regulatory agencies in the United States, and other global agencies as needed
• Provide regulatory oversight in the preparation and review of draft and final submissions/reports
• Work cross-functionally to anticipate the impact of current and emerging trends, identify potential opportunities and threats, and advise departments and project teams accordingly
• Participate in and sometimes lead interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, review, and approval of INDs, INADs, NADAs, BLAs, amendments
• Host FDA/third party regulatory audits and ensure follow up on findings/observations
• Represent eGenesis at company and industry committees, conferences, and organizations
• Ability to work independently while fostering collaboration of team members in other functions

Senior Director, Regulatory Affairs