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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)