Director, Regulatory Capability Development and Knowledge Management

Posted Yesterday
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Cambridge, MA, USA
Hybrid
177K-278K Annually
Expert/Leader
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Takeda exists to create better health for people, brighter future for the world.
The Role
Leads global regulatory capability development and knowledge management for Takeda’s Regulatory Affairs organization. Responsibilities include creating capability frameworks, assessing skills gaps, designing learning and onboarding programs, governing regulatory knowledge repositories, promoting knowledge sharing, measuring program effectiveness, supporting operational excellence, and overseeing vendors and internal teams. The role partners with senior regulatory, HR, learning, and subject matter experts to strengthen workforce readiness, compliance, process adoption, and continuous improvement in a regulated pharmaceutical environment.
Summary Generated by Built In

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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.
  • 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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

USA - MA - Cambridge

U.S. Base Salary Range:

$177,000.00 - $278,080.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 


For information about our benefits, please click here.


EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

LocationsUSA - MA - Cambridge

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Skills Required

  • Bachelor’s degree in education, organizational development, human resources, business, life sciences, communications, 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
  • At least 5 years of experience in research and development or drug development, preferably in Regulatory Affairs, Clinical Development, Pharmacovigilance, or a related function
  • 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
  • Demonstrated communication, facilitation, and stakeholder-management skills, including supporting change adoption across a complex organization

Takeda Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.

  • Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
  • Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
  • Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.

Takeda Insights

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The Company
HQ: Cambridge, MA
50,000 Employees
Year Founded: 1781

What We Do

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world.  We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.   Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.   Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.  

Why Work With Us

We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.

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