Associate Director, Regulatory Affairs
Company: eGenesis
Location: Cambridge
Posted on: January 18, 2026
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Job Description:
Job Description Job Description 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 Associate Director of Regulatory
Affairs is responsible for developing and executing 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 Collaborate cross-functionally 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 7 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 Base pay
range is $193,000 - $210,000. We may use artificial intelligence
(AI) tools to support parts of the hiring process, such as
reviewing applications, analyzing resumes, or assessing responses.
These tools assist our recruitment team but do not replace human
judgment. Final hiring decisions are ultimately made by humans. If
you would like more information about how your data is processed,
please contact us.
Keywords: eGenesis, Nantucket , Associate Director, Regulatory Affairs, Science, Research & Development , Cambridge, Massachusetts
