Who are we? Arbor Biotechnologies, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a portfolio of first-in-class genomic medicines addressing serious diseases for which there are no existing functional cures, with a... Backed by Accel.
About the role
The Director of Regulatory Affairs is responsible for leading regulatory strategy and execution for Abror’s development programs across the portfolio, spanning preclinical and early clinical stages. Reporting to the Chief Medical Officer, this role serves as the Global Regulatory Lead on cross functional program teams and as the primary regulatory point of contact with FDA and other global health authorities.
What they're looking for
- Bachelor’s degree in life sciences or related discipline required, advanced degree preferred
- Minimum of 10 years of experience in biotechnology or pharmaceutical development, including Regulatory Affairs experience
- Demonstrated experience leading or supporting regulatory strategy, submissions, and health authority interactions for preclinical and/or early clinical development programs
- Experience leading FDA interactions and/or IND submissions preferred
- Experience with biologics, gene therapy, or gene-editing products preferred
- Strong written and verbal communication skills, with the ability to synthesize complex scientific data into clear regulatory narratives
More about this role
The Director of Regulatory Affairs is responsible for leading regulatory strategy and execution for Abror’s development programs across the portfolio, spanning preclinical and early clinical stages. Reporting to the Chief Medical Officer, this role serves as the Global Regulatory Lead on cross functional program teams and as the primary regulatory point of contact with FDA and other global health authorities.
The Director provides regulatory guidance to support development decision making and leads regulatory strategy through planning, execution, and health authority engagement appropriate to the stage of development. The role also translates regulatory strategy into actionable submissions, briefing materials, and agency interactions in collaboration with internal subject matter experts, external development partners, CROs, medical writers, and regulatory consultants.
Regulatory Strategy & Program Engagement
- Serve as Global Regulatory Lead on cross functional program teams for development programs across the portfolio.
- Develop, maintain, and execute program level regulatory strategies aligned with corporate objectives and stage of development.
- Define regulatory pathways,...
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