Director, Risk Management & Stakeholder Engagement

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.

Key responsibilities include:

• 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

Key Requirements

• 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.