どんな仕事かAIによる生成

The Senior Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan leads a team of RA TA professionals within the assigned therapeutic area. The role develops and implements group strategies, supports team development and operational excellence, and manages development projects and regulatory activities.

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応募資格

必須

Leadership & Team Management: Demonstrated experience in leading, motivating, and developing diverse and cross-functional teams.
Organizational Skills: Strong ability to prioritize tasks, coordinate multiple projects, and maintain high standards of quality and accuracy.
Communication: Excellent verbal and written communication skills in Japanese and business level in English, with proven ability to collaborate cross-functionally and manage diverse stakeholders.
Problem-Solving: Proactive, analytical, and solution-oriented mindset to identify and resolve challenges efficiently.
Project Management: Proficiency in planning, executing, and monitoring projects to ensure delivery within scope and timelines.
Compliance Orientation: Exceptional attention to detail with a robust understanding of regulatory frameworks and industry requirements.
Bachelor’s or Master’s degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Public Health, Clinical Development, Engineering).
Extensive experience managing teams and/or projects, preferably in Regulatory Affairs and within pharmaceutical or related industries.
In-depth knowledge and hands-on experience in regulatory affairs, including regulatory strategy development and product lifecycle management.

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: Senior ManagerLead and manage the RA TA team
給与: 記載なし
勤務地: Minato City, Tokyo
働き方: 記載なし
学歴: 大学卒業以上
掲載日: 2026/10/13 06:29（23日前）
最終確認: 2026/11/04 20:04（1日前）

仕事内容

Summary of Job Description:

The Senior Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is responsible for leading a team of RA TA professionals within the assigned therapeutic area. This role ensures effective workflow, optimal productivity, professional development, and delivery of high-quality regulatory outputs in a timely manner. The Senior Manager develops and implements group strategies aligned with organizational objectives, provides leadership, mentors staff, drives operational excellence in both regulatory and therapeutic domains, and actively manages development projects as needed.

Major Responsibilities:

Lead and manage the RA TA team by setting clear objectives and performance expectations.
Oversee recruitment, onboarding, and ongoing training and development for all team members.
Allocate projects and responsibilities based on regulatory and therapeutic area expertise, monitor progress, support team members, and ensure timely achievement of deliverables.
Mentor and coach team members to support their professional and career growth.
Direct involvement in development projects and life-cycle management activities, including Package Insert maintenance. Lead and implement local regulatory strategies as appropriate.
Foster a collaborative and high-performing organizational culture within the RA TA group and with cross-functional teams.
Liaise with key internal and external stakeholders (e.g., PMDA, MHLW, global teams) for cross-functional initiatives, including regulatory submissions and therapeutic projects.
Identify, address, and resolve strategic and operational challenges impacting regulatory and therapeutic area activities.
Contribute to regulatory policy intelligence and actively monitor relevant regulatory changes and developments.
Ensure compliance with company policies and all applicable health authority regulations.

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Senior Manager, RA TA Group, Regulatory Affairs(Neurology)

どんな仕事かAIによる生成

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募集要項最終確認 11/4

仕事内容

Summary of Job Description:

Major Responsibilities:

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