Director, Regulatory Affairs

Arbor Biotechnologies - Cambridge, MA

Hiring: Director, Regulatory Affairs Company: Arbor Biotechnologies Location: Cambridge, MA Job Posted Time: 2026-09-02 22:39:31 About the job Required Skills: •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, designation opportunities, and submission sequencing in collaboration with cross functional stakeholders. •Identify regulatory risks and develop mitigation strategies aligned with clinical, nonclinical, and CMC development plans. •Provide regulatory input into development plans to support preclinical programs and early clinical development, with strategies informed and refined through ongoing execution. •Serve as the primary regulatory point of contact with FDA and other global health authorities (e.g., MHRA, EMA). Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!