Senior Manager Regulatory Operations

Job Summary

Leading the Japan team, the full-time Senior Manager Regulatory Operations will manage eCTD publishing and submission processes, oversee regulatory information management systems, and support regulatory technology implementation while working remotely.

Key responsibilities

• Own end-to-end eCTD publishing, submission, and document management for major global regulatory submissions, ensuring compliance and timely delivery
• Administer and enhance global regulatory information management systems and processes to support the Japan team and its clients
• Manage and develop a team of regulatory operations professionals, fostering growth and succession readiness within the team

Required qualifications

• At least 10 years of experience in the pharmaceutical industry with a focus on Regulatory Operations
• 5-10 years of people management experience in a regulatory operations context
• 5+ years of experience with eCTD publishing and managing major regulatory submissions
• Experience with regulatory technology implementation, including tools like Documentum and Veeva Vault
• Bachelor's degree or equivalent experience in Life Sciences, Regulatory Affairs, or a related field