Director, Regulatory Capability Development and Knowledge Management
About The Position
The Director, Regulatory Capability Development and Knowledge Management leads the strategy, design, and execution of programs that build and sustain critical capabilities across Global Regulatory Affairs. The role directs how essential regulatory knowledge is captured, organized, shared, and applied across the organization, partnering with Regulatory leaders, Takeda colleagues, Human Resources, learning teams, and subject matter experts to identify capability and upskilling needs and develop scalable learning solutions. The position strengthens workforce readiness, compliance, and knowledge sharing in a regulated environment. The role advances Operational Excellence by establishing sustainable processes, tools, and governance that support consistent execution and continuous improvement. It oversees capability frameworks, learning and knowledge management programs, content governance, repositories, supporting tools, metrics, and internal and external contributors.
Requirements
- 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.
- 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.
- Working knowledge of Regulatory, Quality, or compliance-focused processes, including inspection readiness and traceable documentation.
- Experience using learning management systems, talent platforms, and knowledge or collaboration tools such as Microsoft SharePoint and Microsoft Teams, or comparable technologies, to support development programs and controlled content environments.
- Demonstrated communication, facilitation, and stakeholder-management skills, with the ability to support change adoption across a complex organization.
Responsibilities
- 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 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 related to 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 to strengthen readiness, adoption, and performance.
- Develop and maintain global frameworks for capturing, curating, classifying, retaining, and retrieving regulatory process information, decisions, and program materials.
- Establish standards for capability assessment, learning path design, content development, and program evaluation in regulated environments.
- Partner with Human Resources to integrate capability development into career development, succession planning, performance development, and change-impact mitigation.
- Identify learning opportunities and facilitate knowledge capture and sharing across the organization, including management of enterprise professional society memberships.
- Evaluate program effectiveness using learner feedback, proficiency measures, and business outcomes, applying insights with Operational Excellence colleagues to 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 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
