Senior Manager, Regulatory Capability & Delivery

Takeda; Boston (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda in Boston seeks a Senior Manager, Business Capability Analyst to bridge regulatory stakeholders with Digital & Technology teams, delivering scalable regulatory data and system capabilities across the GRIDS portfolio.

The role shapes and translates business needs into requirements, ensuring alignment with regulatory objectives while driving end-to-end data and process impact assessment. Strong collaboration and leadership are essential.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 8–12+ years of business analysis experience in life sciences or regulatory domains.
• Experience with regulatory systems (e.g., Veeva RIM).
• Strong understanding of GxP environments and regulatory processes.

Responsibilities

• Partner with Business System Owners and stakeholders to elicit and document business requirements.
• Facilitate workshops to define use cases, scenarios, and regulatory needs.
• Assess end-to-end process and data impacts of new capabilities across regulatory functions.
• Translate business requirements into functional specifications, user stories, and acceptance criteria.
• Collaborate with Digital & Technology teams to support agile delivery and backlog refinement.
• Serve as a key interface between business and technical teams to ensure alignment and clarity.
• Identify opportunities for process optimization, data quality improvements, and capability advancement.
• Support consistent application of business analysis standards, tools, and methodologies.
• Contribute to successful implementation and adoption of regulatory system capabilities.

Skills

Requirements elicitation

Documentation

Regulatory data models

Agile delivery

Stakeholder management

Cross-functional collaboration

Structured thinking

Communication

Continuous improvement

Capability development

Education

Bachelor's degree

Advanced degree preferred

8–12+ years life sciences/regulatory experience

Experience with regulatory systems (e.g., Veeva RIM)

GxP environments & regulatory processes

Tools

Veeva RIM

Job description

Takeda in Boston seeks a Senior Manager, Business Capability Analyst to bridge regulatory stakeholders with Digital & Technology teams, delivering scalable regulatory data and system capabilities across the GRIDS portfolio.

The role shapes and translates business needs into requirements, ensuring alignment with regulatory objectives while driving end-to-end data and process impact assessment. Strong collaboration and leadership are essential.