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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 Manager, Global Regulatory Affairs (GRA) Business Process Office (BPO) is a key contributor who supports continuous improvement, process optimization, and operational excellence efforts across the GRA organization. This role works closely with GRA leadership, process owners, and cross-functional stakeholders to support the assessment, design, implementation, and monitoring of efficient, compliant, regulatory processes. 

The Senior Manager applies established continuous improvement and change management methodologies to help improve ways of working across Global Regulatory Affairs.  The role supports business decision making by providing data, analysis, and practical recommendations that contribute to advancing GRA’s operational effectiveness, compliance with Regulatory requirements and internal company standards, and alignment with business priorities.

How you will contribute:

• Supports the planning and execution of continuous improvement and process optimization activities
• Contributes to cross-functional team efforts to support successful project through effective project planning, coordination, and execution
• Supports the coordination and monitoring of Regulatory operational support provided by internal and/or external resources
• Contributes to the identification and tracking of project risks, issues, and budget considerations

Business Process Owner Network (BPON) Leadership

• Support the execution of standardized documentation, governance artifacts, and performance measures, under the guidance of process owners and function leadership.
• Assist process owners with current-state assessments to identify inefficiencies, risks, and variability, and support the development of future‑state process improvements that are scalable and compliant.
• Provide subject matter expertise related to process design, operational execution, and regulatory excellence.
• Support learning and awareness of continuous improvement principles and methodologies among stakeholders.
• Support application of continuous improvement methodologies into day-to-day operations.

Continuous Improvement Leadership

• Apply Lean, Six Sigma, and continuous improvement methodologies (e.g., DMAIC, value stream mapping, root cause analysis) to identify improvement opportunities across Regulatory processes.

• Contribute to cross‑functional process improvement initiatives, under the direction of senior function leaders.
• Help ensure initiatives have clearly defined scope, deliverables, timelines, and success metrics.

• Support change management activities to promote adoption of new or improved processes, tools, and ways of working.

Governance, Metrics & Reporting

• Assist process owners in defining and tracking key process performance indicators (KPIs) to monitor effectiveness, efficiency, and compliance.
• Prepare and maintain clear, data-driven reporting on improvement initiatives, risks, and progress.
• Support alignment with GRA governance models, quality standards, and regulatory expectations.

Minimum Requirements/Qualifications:

• Bachelor’s degree in Life Sciences, Business Administration, or related field (Advanced degree preferred)
• 5+ years of experience in pharmaceutical and/or biotech industry
• 3+ years of experience in Regulatory Affairs or drug development project management
• Knowledge of Lean, Six Sigma, and continuous improvement methodologies
• Knowledge of the ways KPIs and metrics can be leveraged as tools for monitoring performance and driving continuous improvement
• Prior experience supporting regulatory operations, business process management, or continuous improvement within a regulated industry (pharmaceuticals, biotech, medical devices, or similar).
• Demonstrated experience leading complex, cross‑functional continuous improvement or process transformation initiatives.
• Demonstrated ability to collaborate effectively in cross-functional, matrixed environments.
• Familiarity with regulatory systems, compliance frameworks, and quality control
• Strong analytical, problem‑solving, communication, and stakeholder engagement skills.

Preferred

• Lean Six Sigma certification (Green Belt or equivalent).
• Experience working within a Business Process Office, Center of Excellence, or PMO‑like structure.
• Familiarity with regulatory systems, data, and digital tools that support process optimization.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "remote" following Takeda's Hybrid and Remote Work policy.

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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:

U.S. Base Salary Range:

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. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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.

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Job Exempt