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About the Role

This role will lead the strategy, governance, and execution of risk minimization and patient safety programs for highly regulated products, ensuring compliance with regulatory requirements and maintaining a favorable benefit-risk profile throughout the product lifecycle. As a member of the Japan leadership team, drives organizational development, cross-functional collaboration, and stakeholder engagement across the business.

Responsibilities

• Developing and overseeing risk management and patient safety programs for marketed and pipeline products.
• Ensuring effective operational governance, performance monitoring, and continuous improvement of end-to-end program delivery.
• Leading internal teams and external partners to execute strategic initiatives.
• Partnering with R&D and commercial functions to design and implement risk mitigation strategies for future products.
• Building strong relationships with regulatory authorities, healthcare professionals, patient communities, and internal stakeholders.
• Maintaining high standards of regulatory compliance, operational excellence, and organizational credibility.

Requirements

• Senior leadership role responsible for strategic risk management, governance, and external stakeholder engagement within a highly regulated environment.
• Serves as a key interface between the organization, regulatory bodies, policymakers, healthcare stakeholders, patient communities, and strategic partners to drive risk mitigation initiatives and business objectives.
• Proven track record of influencing and managing senior internal and external stakeholders, including executive leadership, regulatory authorities, government agencies, healthcare organizations, patient advocacy groups, and strategic partners.
• Strong cross-functional leadership experience collaborating with Regulatory Affairs, Medical Affairs, Patient Safety, and other business functions.
• Expertise in strategic risk management, governance, compliance, and stakeholder engagement.
• Excellent communication and relationship-building skills with the ability to navigate complex organizational and external environments.
• Fluent English communication skills, with experience operating in global and cross-cultural settings.

Experience Level

• Senior leadership