Senior Director, Regulatory Affairs

eGenesis

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 01/18/2021
  • Website: egenesisbio.com
  • Company Address: 88 Beacon Street, Apt 54, Somerville, MA, 02143

About eGenesis

eGenesis is a life sciences company focused on development and commercialization of engineered organisms for the benefit of human health. The company's technology is based on the next-generation genome engineering tool set, CRISPR. eGenesis' team of scientists and advisers include world recognized leaders in the field of genome engineering and regenerative medicine.

Job Description

COMPANY MISSION:

At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing. 

POSITION SUMMARY

Reporting to the Chief Operating Officer and based in our Cambridge, MA office, the 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
  • Author, review and critique documents that will be included in regulatory submissions and interactions
  • Work cross-functionally to anticipate the impact of current and emerging trends, identify potential opportunities and threats, and advise departments and project teams accordingly
  • Ensure practices are consistent with corporate regulatory risk posture
  • Host FDA/third party regulatory audits and ensure follow up on findings/observations
  • Represent eGenesis at company and industry committees, conferences, and organizations
  • Determine resourcing needs for the function to ensure company goals are met
  • Ability to work independently while fostering collaboration of team members in other functions

BASIC REQUIREMENTS

  • Bachelor’s degree with 10+ years of experience in Regulatory Affairs (advanced degree preferred)
  • Experience in the successful development and registration of therapeutics, preferably in the area of cell and tissue engineering, including:
    • Requirements for 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 (eg, VIP, INTERACT, pre-IND, IND, NADA, BLA)
    • Negotiation with and presenting to regulatory agencies

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.