Senior Director, Regulatory Affairs
Cambridge, MA
Regulatory Affairs /
Full-Time /
Hybrid
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 Director/Senior Director of Regulatory Affairs is responsible for developing and leading 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.
PRIMARY RESPONSIBILITIES
- 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
BASIC QUALIFICATIONS
- Bachelor’s degree with 10+ years of experience in Regulatory Affairs (advanced degree preferred)
- Experience in the successful development and registration of therapeutics, including:
- Requirements for clinical protocol development, study/trial conduct, data collection, and data analysis
- Knowledge of manufacturing requirements
- Understanding of quality assurance and GxP requirements
- Preparation of meeting requests and submissions (e.g., VIP, INTERACT, pre-IND, IND, NADA, BLA)
- Negotiation with and presenting to regulatory agencies
- Hands-on, roll-up-your-sleeves approach with the ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
