Head, Global Regulatory Affairs Systems

  • Company: Takeda
  • Location: Cambridge, Massachusetts
  • Posted: December 01, 2017
  • Reference ID: 1703208

The role is based in Boston and reports to the Global Head of Development and Medical Systems

The Head, Global Regulatory Affairs Systems will:
  • Partner with Regulatory Affairs organisation to develop, implement and manage global innovative technology solutions aligned to strategic imperatives (from conception of ideas through planning, business case preparation, vendor selection, development, deployment, operations, user satisfaction and experience)
  • Establish strong relationships with executive business partners - stakeholders
  • Realize strategic vision through implementation of application roadmap, including full lifecycle management
  • Coordinate the information needed by GMA for the IT organization’s annual planning process, including budgeting, representing the demand for technology services from the business areas
  • Work with the Global Head of Development and Medical Systems to benchmark GRA IT activity with industry peers in key operational areas with the goal to establish and update best practices to measure and drive performance
  • Consultant to the business areas on technology trends and technology delivery options. Serve as the IT lead on key stakeholder’s teams
  • Drive innovation for GRA aiming at delivering continuous improvement or more significant transformations by leveraging a complete innovation process from ideation to proof of concept.
  • Provide leadership, professional development, coaching and performance management for a team of IT professional


· Bachelor degree or High School degree with 14 years of equivalent work experience

· 10+ years of relevant experience

· Previous IT related experience
· Excellent skills in building multi-cultural relationships via strong collaboration and communication skills
· Excellent ability to work independently but seek management support and guidance as needed
· Strong learning competency
· Experience managing large scale global project teams within R&D
· Experience influencing and managing leadership and stakeholders
· Proven record of leading and managing teams in the research, analysis, selection and implementation of new tools, technologies or services.
· Our ideal candidate has extensive experience planning and managing concurrent projects of varying sizes, and has managed successful global deployments of systems.
· Personal traits sought include innovative, collaborative, inclusive and humble

· Experience supporting global business functions, supporting large, complex and/or global applications and implementing global and/or large applications strongly desired.
· Demonstrated experience in budget management, employee development and performance management strongly desired.
· Experience with formal SDLC methodologies and system validation processes strongly desired.

· Previous experience with application outsourcing and/or vendor management strongly desired.

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