Director, Regulatory Operations, Submissions

Role: Lead global Regulatory Operations, overseeing submission execution for a biopharmaceutical company focused on RAS-addicted cancers, with responsibilities spanning strategic planning, process improvement, and team leadership. Core responsibilities include translating regulatory strategies into operational plans, managing high-quality dossier submissions compliant with standards like eCTD, and collaborating cross-functionally with Regulatory Affairs, Medical Writing, Quality, and Clinical teams. The role involves leading and developing a submissions-focused team, overseeing external vendors, and maintaining SOPs and best practices to optimize submission timelines, quality, and compliance. Qualifications: Bachelor's in life sciences with 12+ years in biotech/pharma, proven leadership in Regulatory Operations, extensive experience with global submission processes, electronic submission standards, and regulatory frameworks. Preferred skills include hands-on publishing experience, familiarity with tools like Veeva RIM and Smartsheet, and global portfolio management. The position requires strategic thinking, strong project management, and excellent communication skills. Location: Redwood City, CA, onsite; salary range: $211K–$264K, with comprehensive benefits. The role emphasizes operational excellence, continuous improvement, and cross-functional partnership to support organizational growth and regulatory success in oncology therapeutics.