Regulatory Support Excellence – Senior Associate

Career Category

Regulatory

Job Description

Job Description

Group Purpose

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.

Job Summary

The Senior Associate, Regulatory Support Excellence 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.

The position focuses on disciplined execution, process adherence, and effective task orchestration to enable consistent, high-quality regulatory delivery.

Key Activities

Regulatory Operations Support

• Execute standardized regulatory operational processes across submissions, reviews, and post-approval activities in alignment with defined workflows
• Coordinate day-to-day regulatory operational tasks in collaboration with Regulatory Assistants to ensure timely and accurate execution
• Review outputs prepared by Regulatory Assistants to ensure completeness, accuracy, and adherence to agreed standards
• Maintain high-quality regulatory documentation and records through disciplined execution

Process & Governance Execution

• Support implementation and consistent application of SOPs, operational standards, and RACI across regulatory activities
• Monitor execution against defined processes, identifying gaps or deviations and escalating issues as appropriate
• Reinforce process discipline within the operational team, including Regulatory Assistants, to ensure sustainable execution

Task Coordination & Workload Management

• Plan, prioritize, and coordinate operational tasks across Regulatory Assistants based on timelines and workload
• Track progress of assigned tasks and proactively address delays, quality issues, or resource constraints
• Provide clear task-level guidance to enable efficient and consistent execution

Cross-functional & System Support

• Support coordination with internal stakeholders to enable smooth regulatory operations
• In response to requests from cross-functional teams, coordinate and support regulatory document formatting activities in collaboration with Regulatory Assistants, ensuring documents meet defined regulatory and submission-ready standards
• Review formatted documents for compliance with established templates, formatting rules, and regulatory expectations prior to further use or submission
• Operate regulatory systems (e.g., RIM and related tools), ensuring data accuracy and timely updates
• Support preparation of meeting materials, minutes, and action tracking as required

Knowledge and Skills

• 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

Education & Experience (Basic)

• Bachelor’s degree
• 3–5 years of experience in regulatory affairs, regulatory operations, or related pharmaceutical functions

Education & Experience (Preferred)

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