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Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, executes regulatory activities for assigned projects or therapeutic areas as a core member of project teams. The role prepares and submits regulatory documents, supports and implements regulatory strategies, and collaborates with internal and external stakeholders to ensure regulatory compliance and improve regulatory processes.

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募集要項最終確認 11/4

職種: 臨床開発・薬事
雇用形態: Full-time
役職: ManagerⅡ
給与: 記載なし
勤務地: Tokyo, Tokyo
働き方: 記載なし
福利厚生: Individual development opportunities and chance to utilise our internal learning platform with a range of learning paths to choose from.The opportunity to be part of a collaborative global working environment with support from passionate colleagues around the globe
掲載日: 2026/10/13 06:28（23日前）
最終確認: 2026/11/04 20:04（1日前）

仕事内容

Summary of Job Description:

Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is accountable for executing regulatory activities within assigned projects or therapeutic areas, acting as a core member of project teams. This role ensures timely and high-quality regulatory deliverables, supports regulatory strategy, and maintains compliance with applicable regulations and company policies. The Manager proactively collaborates with internal and external stakeholders and contributes to the continuous improvement of regulatory processes.

Major Responsibilities:

Execute regulatory affairs activities for assigned projects, including preparation and submission of regulatory documents (e.g., New Drug Applications, PMDA consultations, Clinical Trial Notifications, package inserts) to PMDA/MHLW.
Collaborate with cross-functional project teams (e.g., Clinical Development, Project Management, Commercial) to deliver regulatory input throughout product life-cycle management.
Lead and implement regulatory strategies, considering both global and local requirements.
Interact with PMDA/MHLW and internal stakeholders to facilitate communications, resolve issues, and ensure regulatory compliance.
Monitor and interpret regulatory changes/practices relevant to assigned products/areas; communicate updates to relevant teams.
Support the development and maintenance of regulatory SOPs and best practices, if applicable.
Contribute to departmental or cross-functional initiatives to promote operational efficiency and regulatory excellence, if applicable.

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