求人・転職情報

The Associate Director, Regulatory Affairs, Japan leads the development and implementation of Japan regulatory strategies to secure and maintain market access for products, aligning with global and local business objectives. This role manages regulatory aspects throughout the product lifecycle, provides strategic oversight, and ensures compliance with Japan and ICH requirements. Key responsibilities include preparing and submitting CTN/NDA documents, liaising with health authorities, managing regulatory risks, monitoring regulatory changes, and leading internal teams through recruitment, development, and performance management.

Job Purpose 

At GSK, we are uniting science, technology, and talent to get ahead of disease together. The Evidence Generation
Strategy & Operations Lead is responsible to provide DGP process coordination and study/ project management,
statistic & data management expertise for studies in Japan CPO to ensure the delivery of evidence generation to
support launch readiness, pricing, reimbursement and life cycle management. The role will also partner closely with
the Japan Head of RWE-HO to ensure timely planning and tracking for enterprise strategic and capability building
initiatives, ensuring excellence of teams.  

Key Responsibilities 
Reporting directly to the Japan Head of Real-World Evidence & Health Outcomes, the role will:
• Shape evidence-generation strategy across therapeutic areas and drive cross-portfolio operational synergies.
• Acts as leader to enterprise evidence strategy and operations, covering aspects of evidence synthesis,
analytics and study operations to provide coaching and implement internal standards and processes.
• Responsible for the timing and quality delivery of the study/ projects and organize the regular study
monitor meeting for dashboard management.
• Ensures study quality standards, i.e. no significant compliance (GCP, SOP or applicable regulations)
issue throughout study planning and execution.  
• Redefine processes and ways of working to enable more efficient and effective planning and execution
of data-generation programs, standardizing workflows, reducing duplication and accelerating delivery　across the portfolio.
• Responsible for the quality of outsource service through vendor management.
• Maintains effective communication with internal and external stakeholders.
• Proactively identify and drive cross-TA and cross-portfolio synergies (e.g., data reuse, harmonized studydesigns, shared analytics) to increase efficiency, reduce duplication and accelerate timelines.
• Represents Japan RWE-HO in cross-regional forums on evidence strategy, ensuring alignment with

global RWE-HO initiatives and facilitating two-way knowledge transfer.
• Partners closely with Global RWE-HO to prepare QBRs and townhalls, and to promote best-practice
sharing in Japan and across other regions.

■Position Summary
You will lead epidemiology initiatives in Japan to inform development and lifecycle decisions. You will partner across clinical, safety, regulatory and commercial teams. You will shape study design, manage external partnerships, and translate real-world evidence into clear recommendations. We value curiosity, collaboration, and a practical approach that balances scientific rigour with timely decision-making. Join us to grow your career while helping GSK unite science, technology and talent to get ahead of disease together.

■Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:- Lead design, delivery and interpretation of epidemiology studies and real-world evidence projects in Japan.- Provide clear epidemiologic input to cross-functional teams including clinical development, safety, regulatory and market access.- Manage external partnerships and vendors to access data, deliver studies and ensure quality and timelines.- Produce study documents and outputs: protocols, analysis plans, final reports, regulatory input and scientific communications.- Represent GSK in scientific and regulatory discussions in Japan and with external experts.- Mentor colleagues and contribute to knowledge sharing and process improvements across the Epidemiology team.

オンコロジー領域のメディカルアフェアーズポジション。
※MD資格必須
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