Director, Regulatory Operations

Role: Director of Regulatory Operations responsible for establishing and managing regulatory information management systems and processes at Keros. Objectives: support regulatory needs, ensure compliant submission management, and streamline regulatory data workflows. Responsibilities: oversee all RIM deliverables, manage Health Authority correspondence archives, implement and train on Vault RIM, develop reports and templates, support system validation, and handle eCTD/CTD publishing for major submissions (e.g., INDs, BLAs). Qualifications: BA/BS or equivalent; 12+ years industry experience with at least 7+ years in regulatory operations; extensive knowledge of eCTD, electronic publishing, and Veeva RIM; proficiency in MS Office and Adobe Acrobat; strong attention to detail and collaboration skills. High-Value: experience with biotech regulatory projects, global submission standards, and large-scale RIM systems. WorkSetup: not specified, but likely in a collaborative environment supporting fast-paced biotech operations.