Japan Regulatory Strategy Group Senior Manager Job at Amgen (Tokyo)

Japan Regulatory Strategy Group Senior Manager

Amgen

Location:
Japan , Tokyo

Category:
-

Contract Type:
Not provided

Salary:

Not provided

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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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Job Link Share:

Japan Regulatory Strategy Group Senior Manager

Amgen

Location:
Japan , Tokyo

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 18, 2025

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