Director, Regulatory Capability Development and Knowledge Management

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Job Description

About the Role

The Director, Regulatory Capability Development and Knowledge Management will lead the strategy, design, and execution of programs that build and sustain critical capabilities across Global Regulatory Affairs.

You will direct how essential regulatory knowledge is captured, organized, shared, and applied across the organization. Working closely with Regulatory leaders, Takeda colleagues, Human Resources, learning teams, and subject matter experts, you will identify capability and upskilling needs, develop scalable learning solutions, and strengthen workforce readiness, compliance, and knowledge sharing within a regulated environment.

This role will also advance Operational Excellence by establishing sustainable processes, tools, and governance that support consistent execution and continuous improvement.

How You Will Contribute

• Develop and lead the capability development and knowledge management strategy for Regulatory functions, aligning programs with business priorities and future capability needs.
• Establish and apply capability frameworks, role profiles, and skills models that define the critical capabilities required for regulatory processes, leadership, training effectiveness, and operational execution.
• Partner with Regulatory and business leaders, Human Resources, learning teams, and subject matter experts to assess skills gaps and prioritize development needs associated with new and existing processes, systems, and organizational changes.
• Identify critical organizational knowledge and improve understanding of newly designed or evolving processes.
• Design and oversee scalable onboarding, learning, upskilling, and role-based enablement programs that strengthen readiness, adoption, and performance.
• Develop and maintain global frameworks for the capture, curation, classification, retention, and retrieval of regulatory process information, decisions, and program materials.
• Establish standards for capability assessment, learning path design, content development, and program evaluation within regulated environments.
• Partner with Human Resources to integrate capability development into talent processes, including career development, succession planning, performance development, and change-impact mitigation.
• Identify learning opportunities for colleagues and facilitate the capture and sharing of knowledge across the organization, including the management of enterprise professional society memberships.
• Evaluate program effectiveness using learner feedback, proficiency measures, and business outcomes. Apply insights in partnership with Operational Excellence colleagues to continuously improve learning and knowledge management solutions.
• Define and monitor metrics for knowledge reuse, content effectiveness, adoption, and business impact.
• Oversee external vendors, consultants, and internal team members supporting capability development, training, knowledge transfer, and knowledge accessibility initiatives.
• Lead the development and management of repositories, collaboration spaces, and supporting tools that provide controlled access, usability, content clarity, and relevance.
• Promote knowledge-sharing behaviors through targeted communications, forums, training, and role-based enablement.

Skills and Qualifications

• Bachelor’s degree in education, organizational development, human resources, business, life sciences, communications, or a related field, or equivalent relevant experience.
• At least 10 years of relevant experience in capability development, knowledge management, learning and development, talent management, organizational effectiveness, or a related discipline within a regulated or global environment. This should include at least 5 years of experience in research and development or drug development, preferably within Regulatory Affairs, Clinical Development, Pharmacovigilance, or a related function.
• Demonstrated experience designing and implementing capability frameworks, capability development programs, knowledge repositories, or workforce development initiatives in regulated or highly structured environments.
• Experience partnering with senior leaders and cross-functional stakeholders in complex organizations undergoing process, system, or operating model changes.
• Knowledge of adult learning principles, curriculum design, assessment methods, learning measurement practices, and role-based enablement.
• Understanding of content governance, taxonomy, information architecture, document lifecycle practices, and controlled-documentation principles.

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