Senior Director Regulatory Operations

Role: Senior Director of Regulatory Operations overseeing global regulatory submission production, maintenance, and information management for Arcus’s biopharma portfolio. Responsibilities include developing and executing submission strategies, managing electronic and paper submission processes, overseeing vendor relationships, ensuring compliance with evolving regulations, and supporting inspection readiness. The role involves leadership in regulatory systems development, collaboration across departments to ensure timely submissions, and continuous improvement of operational workflows. Qualifications: Bachelor’s or Master’s in Life Sciences with 10-12 years’ regulatory experience, including at least 6 years in a leadership capacity; strong knowledge of worldwide regulatory submission formats (eCTD, NeeS), and experience with submission tools like Veeva Vault. Skills include project management, regulatory compliance, cross-functional collaboration, and vendor oversight. High-value specifics: focus on global regulatory submissions in a fast-paced biopharma environment, with responsibilities spanning GxP systems, regulatory intelligence, and compliance with international guidelines. Location: preferred at Hayward or Brisbane, CA, or remote; travel not specified but likely moderate. Key: leadership in regulatory systems, global submission management, and compliance with international regulations to support biopharma product development.