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
- Supports planning and execution of continuous improvement and process optimization activities
- Coordinates and executes cross-functional project work through effective planning
- Coordinates and monitors regulatory operational support from internal and/or external resources
- Identifies and tracks project risks, issues, and budget considerations
Business Process Owner Network (BPON) Leadership
- Supports execution of standardized documentation, governance artifacts, and performance measures
- Assists process owners with current-state assessments to identify inefficiencies, risks, and variability; supports future-state improvements that are scalable and compliant
- Provides subject matter expertise in process design, operational execution, and regulatory excellence
- Supports continuous improvement awareness among stakeholders and application into day-to-day operations
Continuous Improvement Leadership
- Applies Lean, Six Sigma, and continuous improvement methods (e.g., DMAIC, value stream mapping, root cause analysis)
- Contributes to cross-functional process improvement initiatives; ensures clear scope, deliverables, timelines, and success metrics
- Supports change management to drive adoption of new/improved processes and ways of working
Governance, Metrics & Reporting
- Defines and tracks KPIs to monitor effectiveness, efficiency, and compliance
- Prepares data-driven reporting on initiatives, risks, and progress
- Supports alignment with GRA governance, quality standards, and regulatory expectations
Minimum Requirements/Qualifications
- Bachelor’s degree in Life Sciences, Business Administration, or related field (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; KPI/metrics utilization
- Experience in regulated-industry regulatory operations, business process management, or continuous improvement
- Experience leading complex, cross-functional process transformation initiatives
- Strong analytical, problem-solving, communication, and stakeholder engagement skills
Preferred
- Lean Six Sigma Green Belt (or equivalent)
- Experience in Business Process Office/Center of Excellence/PMO-like structure
- Familiarity with regulatory systems, data, and digital tools for process optimization
- Supports planning and execution of continuous improvement and process optimization activities
- Coordinates and executes cross-functional project work through effective planning
- Coordinates and monitors regulatory operational support from internal and/or external resources
- Identifies and tracks project risks, issues, and budget considerations
Business Process Owner Network (BPON) Leadership
- Supports execution of standardized documentation, governance artifacts, and performance measures
- Assists process owners with current-state assessments to identify inefficiencies, risks, and variability; supports future-state improvements that are scalable and compliant
- Provides subject matter expertise in process design, operational execution, and regulatory excellence
- Supports continuous improvement awareness among stakeholders and application into day-to-day operations
Continuous Improvement Leadership
- Applies Lean, Six Sigma, and continuous improvement methods (e.g., DMAIC, value stream mapping, root cause analysis)
- Contributes to cross-functional process improvement initiatives; ensures clear scope, deliverables, timelines, and success metrics
- Supports change management to drive adoption of new/improved processes and ways of working
Governance, Metrics & Reporting
- Defines and tracks KPIs to monitor effectiveness, efficiency, and compliance
- Prepares data-driven reporting on initiatives, risks, and progress
- Supports alignment with GRA governance, quality standards, and regulatory expectations
Minimum Requirements/Qualifications
- Bachelor’s degree in Life Sciences, Business Administration, or related field (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; KPI/metrics utilization
- Experience in regulated-industry regulatory operations, business process management, or continuous improvement
- Experience leading complex, cross-functional process transformation initiatives
- Strong analytical, problem-solving, communication, and stakeholder engagement skills
Preferred
- Lean Six Sigma Green Belt (or equivalent)
- Experience in Business Process Office/Center of Excellence/PMO-like structure
- Familiarity with regulatory systems, data, and digital tools for process optimization