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Amgen Logo Amgen · IT - Administration

Japan Regulatory Strategy Manager

Japan, Tokyo · Job Posted April 23, 2026
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Job Description

Amgen is a global leader in biotechnology with a history of more than four decades of pioneering breakthroughs. Our commitment to science has led us to discover and develop innovative therapies that significantly improve patients' lives. We also invest in cutting-edge manufacturing and support services to deliver these therapies worldwide. Japan and the Asia Pacific (JAPAC) region represent the fastest-growing area for Amgen. We are currently seeking a qualified candidate for the role of Japan Regulatory Strategy Manager (Regulatory Affairs Mgr) in Tokyo, Japan.

Job Responsibility

  • 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
  • Developing and implementing the Japan regulatory strategy, aligned with global regulatory strategy
  • Providing guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
  • Proactively influencing developing the global regulatory strategy so that Japan developments are aligned
  • Consistently looking for opportunities to accelerate the developments/approval and/or increase the value of the program
  • Contributing to the filing plan by advising and discussing with the local and global cross-functional teams
  • Leading the preparation of regulatory submissions, which may include New Drug Applications (NDAs), briefing documents for various types of PMDA consultations, Clinical Trial Notifications (CTNs), and Orphan Drug Applications in Japan
  • Ensuring that regulatory submissions are made on time and meet corporate and local regulatory requirements
  • Collaborating with Clinical Study Operations teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements
  • Ensuring that local labels are developed and maintained in line with local regulations and Amgen standards and procedures
  • Proactively leading to develop regulatory strategies and/or mitigate regulatory risks across RA Japan and/or across Amgen
  • Leading process standardization/simplification to improve efficiency in regulatory processes
  • Consistently demonstrating Amgen leadership behaviors
  • Influencing developing global regulatory strategies so that Japan development strategies are aligned
  • Increasing visibility of RA Japan
  • Providing strong supports to the Japan Regulatory Strategy Group Head
  • Working cross-functionally with various Amgen teams related to NDAs, PMDA consultations and CTNs
  • Communicating clearly and in a timely manner with key stakeholders across the business
  • Providing subject matter expert support for local, regional, and global initiatives
  • Acting as the primary interface with MHLW and PMDA for product approval and clinical development
  • Leading and contributing to strategy for HA interactions
  • Attending HA meetings
  • Developing and maintaining a good relationship with HAs in Japan to facilitate drug approvals
  • Engaging with local trade associations to shape the external environment, monitoring national legislation, and providing feedback
  • Maintaining regulatory compliance for all documents submitted to HA and post-approval commitments
  • Supporting monitoring, auditing, and self-assessment activities under the compliance framework
  • Contributing to development and implementation of country-specific compliance procedures and working practices

Requirements

  • Bachelor's degree and 10+ years of directly related experience including 5+ years of experience in Regulatory Affairs
  • 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
  • Ability to 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
  • Communication skills in English (TOEIC score ≥860 desirable)
  • Native level Japanese
  • Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools

What we offer

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
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