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Amgen Logo Amgen · -

Regulatory Support Excellence – Senior Associate

Japan, Tokyo · Job Posted February 13, 2026
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Job Description

To support the Regulatory Support Excellence function by ensuring high-quality, consistent, and efficient execution of Japan Regulatory operations, enabling reliable delivery across regulatory activities. The Senior Associate supports the day-to-day execution of regulatory operational processes, documentation, and governance under the direction of the Sr. Manager. This role works in close collaboration with Regulatory Assistants, coordinating and overseeing routine operational activities to ensure tasks are executed accurately, on time, and in alignment with defined processes.

Job Responsibility

  • Execute standardized regulatory operational processes across submissions, reviews, and post-approval activities
  • Coordinate day-to-day regulatory operational tasks in collaboration with Regulatory Assistants
  • Review outputs prepared by Regulatory Assistants to ensure completeness, accuracy, and adherence to agreed standards
  • Maintain high-quality regulatory documentation and records
  • Support implementation and consistent application of SOPs, operational standards, and RACI
  • Monitor execution against defined processes, identifying gaps or deviations
  • Plan, prioritize, and coordinate operational tasks across Regulatory Assistants
  • Track progress of assigned tasks and proactively address delays, quality issues, or resource constraints
  • Provide clear task-level guidance
  • Support coordination with internal stakeholders
  • Coordinate and support regulatory document formatting activities
  • Review formatted documents for compliance with established templates, formatting rules, and regulatory expectations
  • Operate regulatory systems (e.g., RIM and related tools), ensuring data accuracy and timely updates
  • Support preparation of meeting materials, minutes, and action tracking

Requirements

  • Bachelor’s degree
  • 3–5 years of experience in regulatory affairs, regulatory operations, or related pharmaceutical functions
  • Solid understanding of regulatory operations and document management
  • Strong attention to detail and execution discipline
  • Ability to manage multiple tasks and timelines concurrently
  • Clear and professional communication skills in Japanese and English
  • Collaborative mindset with a strong sense of accountability

Nice to have

  • Experience supporting regulatory submissions or regulatory lifecycle management
  • Hands-on experience with regulatory systems (e.g., RIM)

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