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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

The Senior Director, GRA OCM, Training & Knowledge Management is a senior strategic leader within Global Regulatory Affairs (GRA), responsible for shaping and executing the vision for organizational change, capability development, and knowledge stewardship across the regulatory function. Reporting to the Executive Director, Head of Operational Excellence, this role drives enterprise-aligned transformation by embedding change management strategies, scalable training programs, and centralized knowledge systems that enable regulatory excellence and operational agility.

As a key partner to cross-functional teams, including the GRA Initiatives PMO, GRA Center of Excellence, and GRA Compliance—the Senior Director ensures that change initiatives are effectively communicated, adopted, and sustained. This role also leads the development of role-based learning frameworks, AI-enhanced training content, and the GRA Academy, fostering a culture of continuous learning and improvement. The ideal candidate brings deep expertise in regulatory operations, strategic delivery, and people leadership, with a proven ability to influence at all levels of a global matrixed organization.

How you will contribute:

• Lead GRA’s representation in the R&D Change Management Coalition, sharing methodologies and best practices with the GRA Community.

• Develop and oversee execution of change management strategies for GRA and enterprise-level initiatives.

• Guide change management and communications planning and delivery for change initiatives, including awareness sessions, hypercare, and stakeholder engagement.

• Own the training profile and assignment management process, ensuring alignment with role-based learning and regulatory requirements.

• Drive the development of eLearning content and functional guides, integrating AI-driven summaries and Veeva QualityDocs binders.

• Own and further curate the GRA Academy as a centralized SharePoint library of training materials and knowledge assets.

• Collaborate with PMO and Business Process Office (BPO) leads to ensure change management and training strategies are embedded in project planning and execution.

• Define and monitor KPIs for training effectiveness and change adoption, including risk tracking for delayed implementations.

• Serve as a key partner to GRA Compliance for continuous improvement and CAPA resolution.

Minimum Requirements/Qualifications:

• Bachelor’s degree in Life Sciences, Business, or related field; advanced degree preferred.

• 12+ years of experience in pharmaceutical/biotech industry, with 8+ years in regulatory affairs, change management, or learning development.

• Demonstrated success in leading OCM and training functions within a global matrix organization.

• Experience in applying change management methodologies (ADKAR, Kotter, Prosci, etc.).

• Experience with Veeva, SuccessFactors LMS, and SharePoint-based knowledge systems.

• PMP or equivalent certification preferred.

• Strategic Leadership: Ability to set vision and direction f