Manager, Regulatory Submission Project Management
Regeneron · Tokyo
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Role summary
Regeneron seeks a regulatory submission project management manager in Tokyo to oversee compliant submissions to Japanese health authorities. The role involves coordinating with internal and external teams, managing submission timelines using Veeva Vault RIM, and ensuring adherence to PMDA and ICH guidelines. This hybrid position requires 6+ years of pharmaceutical experience, fluency in Japanese, and expertise in regulatory submission systems.
What they're looking for
- Bachelor's degree or equivalent professional experience
- 6+ years pharmaceutical industry or related experience
- Fluency in Japanese and English proficiency
- Strong knowledge of PMDA, MHLW, ICH, and regulatory requirements
- Experience with Veeva Vault RIM and docuBridge submission systems
- eCTD preparation and submission process expertise
- Proficiency in Microsoft Office and Adobe Acrobat
What you'll be doing
- Ensure consistency and standardization across regulatory submissions
- Support PMDA consultations, clinical trial notifications, and NDA processes
- Track submission deliverables in Veeva Vault RIM through submission objects
- Manage submission readiness with regulatory publishing and external vendors
- Review submission content plans for compliance with health authority guidelines
Privacy & handoff
This role links to Regeneron's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.