Senior Director Regulatory Operations

Role: Senior Director of Regulatory Operations overseeing regulatory submission processes, compliance, and information management for Arcus’s product portfolio. Responsibilities include managing electronic and paper submission workflows, developing and executing submission strategies aligned with global regulatory plans, overseeing vendor contracts, ensuring compliance with evolving regulations, and implementing regulatory systems like eCTD platforms. The role involves cross-functional collaboration across Regulatory Affairs teams, external vendors, and regulatory agencies, with a focus on submission quality, timeliness, and compliance. Qualifications: Bachelor’s or Master’s in Life Sciences with 10-12 years’ regulatory experience, including at least 6 years in leadership; expertise in electronic submission tools (eCTD, Veeva Vault), GxP standards, and global regulations; strong project management, communication, and team management skills. HighValue: Experience with electronic submissions (eCTD, NeeS), regulatory systems, and global regulatory compliance; leadership in regulatory operations within biopharma, preferably in biologics or small molecules, with a focus on innovation and continuous improvement. Location: Remote or at Hayward/Brisbane, CA; travel not specified.