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 businessLead definition of regulatory milestones and ensure that the company remains on track to support achievement of those milestonesLead and manage consultants and CROs who are charged to support regulatory activitiesManage all activities pertaining to interactions and communications with FDA and other regulatory agencies in the United States, and other global agencies as neededProvide regulatory oversight in the preparation and review of draft and final submissions/reportsWork cross-functionally to anticipate the impact of current and emerging trends, identify potential opportunities and threats, and advise departments and project teams accordinglyParticipate 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, amendmentsHost FDA/third party regulatory audits and ensure follow up on findings/observationsRepresent eGenesis at company and industry committees, conferences, and organizationsAbility 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 analysisKnowledge of manufacturing requirementsUnderstanding of quality assurance and GxP requirementsPreparation of meeting requests and submissions (e.g., VIP, INTERACT, pre-IND, IND, NADA, BLA)Negotiation with and presenting to regulatory agenciesHands-on, roll-up-your-sleeves approach with the ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected eventsBase pay range is $161,600 - $242,400
