Submission Manager Japan

Summary

Leads and delivers high quality submissions (electronic and/or paper) successfully to Japanese Health Authorities. Archives submitted dossiers (electronic and/or paper) in a timely manner. Support users of RA IT systems and maintain the systems in collaboration with DevIT and global RA Operations.

About the Role

Major Accountabilities

• Lead regulatory dossier publishing (paper / electronic) for major regulatory event (NDA, Expert Review, Drug Committee, Pharmaceutical Affairs Committee and other small submissions to Japanese HA) with minimal supervision
• Archive all regulatory submissions (Approval Letter, Minor Change Notification, BB, Answers to HA Questions, CTDs)
• Manage the company seal guideline
• Manage the 3rd party vendors for compilation of electronic/paper dossier (printing company etc.)
• Lead information technologies in RA-J as Business Lead in IT project
• Support RA-J colleagues when they have a trouble in using RA IT system
• Provide RA IT system training for RA-J colleague as Business Administrator
• Enter / maintain DRAGON data as DRAGON editor
• Improve Ops productivity by refining / developing SOPs, WPs, manuals, guidance
• Improve company-wide regulatory submission process
• Coach Ops associates to enhance their performance in all areas covered by RA Ops
• Strengthen relationship with other line functions, Global RA Ops, Industrial Parties
• Advocate continuous improvement of quality
• Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
• 100% timely delivery of all training requirements including compliance

• Life Sciences or pharmaceutical in University
• Ph.D. or Master degree, and Pharmacist license is desirable

• 5 years or more experience in pharmaceutical drug development
• Demonstrate various knowledge in the requirements for regulatory submissions and regulatory operations
• Advanced capabilities to proceed tasks in regulatory operations work with multiple regulatory submission projects even under uncertain situations
• Experiences in IT systems utilized in regulatory operations
• Design the structure and content of paper and electronic archives and databases
• Situational leadership and team management skills for driving team and people development in align with organizational visions and commitment
• Advanced interpersonal and communication / negotiation skills (written and verbal)
• Extensive experience in process improvement proposal and its implementation through cross-functional collaboration
• Planning and tracking skills with ability to capture details and summarize across projects in organization
• Well organized, focused on results, capable of managing multiple projects, excellent time management skills with respect to priorities and self-management
• Train and mentor associates in operational excellence
• Business use level of Japanese, and basic English (oral and written)

• Infuluent Japanese (reading, writing, speaking)
• English as business level