Summary
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
Background
Education
- Life Sciences or pharmaceutical in University
- Ph.D. or Master degree, and Pharmacist license is desirable
Experience/Professional requirement
- 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)
Language
- Infuluent Japanese (reading, writing, speaking)
- English as business level
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