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Japan Regulatory Strategy Group Senior Manager

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Amgen

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Location:
Japan , Tokyo

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Category:
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Salary:

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Job Description:

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regulatory strategies and plans; providing strategic regulatory expertise for drug development; interfacing with regulatory authorities; aligning with key cross-functional partners; integrating into Amgen’s commercialization process; continuously improving business processes; and developing our talent. The Japan Regulatory Strategy Group Sr Mgr may be assigned to multiple Amgen products for product-specific activities.

Job Responsibility:

  • Develops and implements the Japan regulatory strategy
  • Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
  • Proactively influence developing the global regulatory strategy
  • Consistently look for opportunities to accelerate the developments/approval
  • Contributes to the filing plan by advising and discussing with the local and global cross-functional teams
  • Leads or oversees the preparation of regulatory submissions
  • Ensures that regulatory submissions are made on time and meet requirements
  • Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies
  • Ensures that local labels are developed and maintained
  • Proactively lead to develop regulatory strategies and/or mitigate regulatory risks
  • Lead process standardization/simplification to improve efficiency
  • Facilitate strategically using vendors
  • Consistently demonstrate Amgen leadership behaviors
  • Increase visibility of RA Japan
  • Provide strong supports to the Japan Regulatory Strategy Group Head
  • Provide strong supports to the Japan Regulatory Head
  • Works cross-functionally with the various Amgen teams
  • Communicates clearly and in a timely manner with key stakeholders
  • Provides subject matter expert support for local, regional, and global initiatives
  • Acts as the primary interface with MHLW and PMDA for product approval and clinical development
  • Leads and contributes to strategy for HA interactions
  • Attends HA meetings
  • Develops and maintain a good relationship with HAs in Japan
  • Engages with local trade associations to shape the external environment, monitors national legislation
  • Maintains regulatory compliance for all documents submitted to HA and post-approval commitments
  • Supports the monitoring, auditing, and self-assessment activities
  • Contributes to the development and implementation of country-specific compliance procedures and working practices

Requirements:

  • Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
  • Communication skills in English (TOEIC score ≥860 desirable)
  • Native level Japanese
  • Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools
  • Ability to develop and lead effective teams
  • Ability to work in matrix environments including cross-functional and global teams
  • Ability to work under minimal direction with a medium degree of autonomy
  • Analytical skills to evaluate and interpret complex situations and problems
  • Ability to anticipate and prevent potential problems
  • Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives
  • Understanding of regulatory activities and how they affect projects and processes
  • Ability to understand and communicate scientific and clinical information
  • Organizational, communication, and time management skills needed to manage multiple assignments and processes

Nice to have:

  • Advanced degree preferred
  • In-depth regulatory experience
  • Knowledge of Japan legislation and regulations relating to medicinal products
  • Knowledge of drug development Scientific/Technical Excellence
  • Teamwork
  • Communication skills both oral and written
  • Ability to understand and communicate scientific/clinical information

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
Hybrid work
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