Position Japan Regulatory Strategy Manager
Amgen · Tokyo, Japan
RegulatoryFull-timeCompany career page
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Role summary
Amgen seeks a Japan Regulatory Strategy Manager in Tokyo to develop and execute regulatory strategies for drug approvals and clinical trials in Japan. The role involves interfacing with Japanese health authorities, coordinating cross-functional teams, and aligning local regulatory strategies with global initiatives.
What they're looking for
- Bachelor's degree with 10+ years directly related regulatory experience
- 5+ years in regulatory affairs roles
- Deep knowledge of Japan pharmaceutical regulations and PMDA requirements
- Advanced degree preferred
- Fluent English language skills; ability to communicate complex scientific information
- Experience leading teams in matrix and cross-functional environments
- Strong analytical and problem-solving skills with minimal supervision needed
What you'll be doing
- Develop and implement Japan regulatory strategies aligned with global regulatory approach
- Lead preparation of regulatory submissions including NDAs, PMDA consultation documents, and clinical trial notifications
- Interface with MHLW and PMDA as primary contact for product approvals and clinical development
- Collaborate with clinical, commercial, and cross-functional teams on drug development planning and execution
- Support process standardization and monitor compliance with regulatory requirements post-approval
Privacy & handoff
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