Senior Manager, Business Process Office, Global Regulatory Affairs (GRA)
Takeda
June 25, 2026
Remote
United States
$137,000 - $215,270 USD yearly
Corporate Functions
How you will contribute
- Support planning and execution of continuous improvement and process optimization activities.
- Coordinate cross-functional project efforts through effective planning, coordination, and execution.
- Coordinate and monitor Regulatory operational support from internal and/or external resources.
- Identify and track project risks, issues, and budget considerations.
Business Process Owner Network (BPON) Leadership
- Execute standardized documentation, governance artifacts, and performance measures under process owners/function leadership.
- Assist current-state assessments to identify inefficiencies, risks, and variability; support scalable, compliant future-state improvements.
- Provide subject matter expertise in process design, operational execution, and regulatory excellence.
- Support learning/awareness of continuous improvement principles and methodologies.
- Apply continuous improvement methodologies in day-to-day operations.
Continuous Improvement Leadership
- Apply Lean/Six Sigma and continuous improvement tools (e.g., DMAIC, value stream mapping, root cause analysis).
- Contribute to cross-functional process improvement initiatives; define scope, deliverables, timelines, and success metrics.
- Support change management for adoption of improved processes/tools/ways of working.
Governance, Metrics & Reporting
- Define and track KPIs for effectiveness, efficiency, and compliance.
- Maintain data-driven reporting on initiatives, risks, and progress.
- Support alignment with GRA governance models, quality standards, and regulatory expectations.
Minimum Requirements
- Bachelor’s degree (Life Sciences/Business Administration or related); advanced degree preferred.
- 5+ years in pharma/biotech; 3+ years in Regulatory Affairs or drug development project management.
- Knowledge of Lean/Six Sigma/continuous improvement and KPI/metrics usage.
- Experience with regulatory operations/business process management/continuous improvement in regulated industries.
- Experience leading complex cross-functional continuous improvement/process transformation.
- Collaboration in cross-functional matrix environments; familiarity with regulatory systems/compliance/quality control.
- Strong analytical, problem-solving, communication, and stakeholder engagement.
Preferred
- Lean Six Sigma (Green Belt or equivalent).
- Business Process Office/CoE/PMO-like experience.
- Familiarity with regulatory systems, data, and digital tools for process optimization.
Compensation & Benefits (explicitly stated)
- U.S. base salary range: $137,000.00–$215,270.00 (location: Massachusetts - Virtual). Possible eligibility for incentives and benefits including medical/dental/vision, 401(k), disability, life insurance, tuition reimbursement, paid time off, and up to 80 hours sick time and up to 120 hours paid vacation for new hires.
Application Instructions
- Click “Apply” to begin the employment application process.
- Support planning and execution of continuous improvement and process optimization activities.
- Coordinate cross-functional project efforts through effective planning, coordination, and execution.
- Coordinate and monitor Regulatory operational support from internal and/or external resources.
- Identify and track project risks, issues, and budget considerations.
Business Process Owner Network (BPON) Leadership
- Execute standardized documentation, governance artifacts, and performance measures under process owners/function leadership.
- Assist current-state assessments to identify inefficiencies, risks, and variability; support scalable, compliant future-state improvements.
- Provide subject matter expertise in process design, operational execution, and regulatory excellence.
- Support learning/awareness of continuous improvement principles and methodologies.
- Apply continuous improvement methodologies in day-to-day operations.
Continuous Improvement Leadership
- Apply Lean/Six Sigma and continuous improvement tools (e.g., DMAIC, value stream mapping, root cause analysis).
- Contribute to cross-functional process improvement initiatives; define scope, deliverables, timelines, and success metrics.
- Support change management for adoption of improved processes/tools/ways of working.
Governance, Metrics & Reporting
- Define and track KPIs for effectiveness, efficiency, and compliance.
- Maintain data-driven reporting on initiatives, risks, and progress.
- Support alignment with GRA governance models, quality standards, and regulatory expectations.
Minimum Requirements
- Bachelor’s degree (Life Sciences/Business Administration or related); advanced degree preferred.
- 5+ years in pharma/biotech; 3+ years in Regulatory Affairs or drug development project management.
- Knowledge of Lean/Six Sigma/continuous improvement and KPI/metrics usage.
- Experience with regulatory operations/business process management/continuous improvement in regulated industries.
- Experience leading complex cross-functional continuous improvement/process transformation.
- Collaboration in cross-functional matrix environments; familiarity with regulatory systems/compliance/quality control.
- Strong analytical, problem-solving, communication, and stakeholder engagement.
Preferred
- Lean Six Sigma (Green Belt or equivalent).
- Business Process Office/CoE/PMO-like experience.
- Familiarity with regulatory systems, data, and digital tools for process optimization.
Compensation & Benefits (explicitly stated)
- U.S. base salary range: $137,000.00–$215,270.00 (location: Massachusetts - Virtual). Possible eligibility for incentives and benefits including medical/dental/vision, 401(k), disability, life insurance, tuition reimbursement, paid time off, and up to 80 hours sick time and up to 120 hours paid vacation for new hires.
Application Instructions
- Click “Apply” to begin the employment application process.