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eGenesis, Inc. · 2 months ago

Associate Director, Regulatory Affairs

Cambridge, MA

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$193K/yr - $210K/yr

7+ years exp

eGenesis, Inc. is dedicated to providing solutions for organ failure through genome engineering. The Associate Director of Regulatory Affairs will develop and execute regulatory strategies, ensuring compliance with industry standards and managing interactions with regulatory agencies.

BiopharmaBiotechnologyGeneticsLife ScienceMedical

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

Qualification

Regulatory AffairsRegulatory strategy developmentFDA interactionsClinical protocol developmentQuality assurance knowledgeCross-functional collaborationNegotiation skillsProject management

Required

Bachelor's degree with 7+ years of experience in Regulatory Affairs

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

Preferred

advanced degree preferred

Company

eGenesis, Inc.

eGenesis is revolutionizing the field of transplantation with an unparalleled, multiplexed gene editing platform for the development of human-compatible organs, tissues and cells.

Founded in 2014

Cambridge, Massachusetts, USA

51-200 employees