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Arbor Biotechnologies is a clinical-stage gene editing company developing first-in-class genomic medicines for serious diseases including ALS and primary hyperoxaluria type 1. The Director of Regulatory Affairs will lead regulatory strategy and execution across the company's development portfolio, spanning preclinical through early clinical stages.
Reporting to the Chief Medical Officer, you will serve as the Global Regulatory Lead on cross-functional program teams and act as the primary regulatory point of contact with the FDA and other global health authorities. Key responsibilities include developing and executing program-level regulatory strategies aligned with corporate objectives and development stage, defining regulatory pathways and submission sequencing in collaboration with clinical, nonclinical, and CMC teams, and identifying regulatory risks with mitigation strategies.
You will provide regulatory guidance to support development decision-making, translate regulatory strategy into actionable submissions and briefing materials, and lead health authority engagement appropriate to each program's stage. This involves close collaboration with internal subject matter experts, external development partners, CROs, medical writers, and regulatory consultants.
The role requires expertise in gene therapy and advanced therapeutic regulatory pathways, strong cross-functional leadership, and the ability to navigate complex regulatory landscapes across multiple jurisdictions. You will be instrumental in advancing Arbor's portfolio of genomic medicines from development through regulatory milestones.
