Director, Regulatory Operations

Role: Director of Regulatory Operations at Keros, responsible for establishing and leading regulatory information management (RIM) functions. Objectives include overseeing regulatory deliverables, managing submission lifecycle, and supporting regulatory system infrastructure. Responsibilities encompass managing Health Authority correspondence, developing training for Veeva Vault RIM, maintaining submission archives, producing reports and dashboards, supporting system validation, and providing eCTD/CTD publishing services for INDs and BLAs. Qualifications: BA/BS or equivalent; 12+ years industry experience with at least 7+ years in regulatory operations; expertise in regulatory document management, eCTD publishing, and systems like Veeva Vault RIM; proficiency in MS Office and Adobe Acrobat. Preferred: prior experience managing large-scale regulatory projects within biotech. HighValue: focus on regulatory submissions (IND/BLA), electronic publishing, Veeva Vault RIM, and cross-functional collaboration with Regulatory Affairs, CMC, and Quality. Work setup: not specified; likely hybrid or office-based given system management and training responsibilities.