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Arbor Biotechnologies, a gene editing company based in Cambridge, MA, is seeking a Manager of Regulatory Affairs to support an expanding portfolio of gene editing programs. Reporting to the Director of Regulatory Affairs, you will drive regulatory execution across internal and partnered development programs, manage health authority interactions, and coordinate cross-functional activities to advance multiple programs toward IND/CTA submission.
Key responsibilities include coordinating preparation and execution of regulatory submissions (health authority meeting packages, IND/CTA amendments, annual reports, and future submissions), partnering with Clinical, CMC, Nonclinical, Quality, and Program Management teams as well as external partners to execute regulatory milestones, and coordinating document review cycles and submission readiness activities. You will maintain regulatory timelines, trackers, submission plans, and regulatory commitments, while managing RIMS/document repositories, compliance records, and inspection-ready regulatory documentation.
The role is ideal for a collaborative, scientifically minded regulatory professional who thrives in a fast-paced biotechnology environment. You are driven by purpose and curiosity, take ownership, think boldly, and stay resilient through challenge. You lead with humility, value diverse perspectives, and prioritize team success. Arbor's lead program, ABO-101 for primary hyperoxaluria type 1, is progressing into clinical trials, with research and development focused on genomic diseases of the liver and CNS for which there are no existing functional cures.
