Senior Regulatory Capability Lead

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

Job summary

Takeda Pharmaceutical Company Limited in Boston, MA seeks a Senior Manager, Business Capability Analyst to align regulatory business needs with Digital & Technology solutions. You will elicit requirements, define use cases, and ensure scalable, compliant data and system capabilities across the GRIDS portfolio.

The role focuses on translating business needs into functional specs, collaborating with IT, and driving process optimization within GxP regulatory environments.

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.
• Requirements elicitation, documentation, and management.
• Translation of business needs into structured technical artifacts.
• Understanding of regulatory data models and process flows.
• Experience working within Agile or hybrid delivery environments.

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

Stakeholder management

Cross-functional collaboration

Structured thinking

Problem solving

Clear communication

Leadership

Education

Bachelor's degree required

Advanced degree preferred

8-12+ years of experience

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

GxP and regulatory processes understanding

Tools

Veeva RIM

Job description

Takeda Pharmaceutical Company Limited in Boston, MA seeks a Senior Manager, Business Capability Analyst to align regulatory business needs with Digital & Technology solutions. You will elicit requirements, define use cases, and ensure scalable, compliant data and system capabilities across the GRIDS portfolio.

The role focuses on translating business needs into functional specs, collaborating with IT, and driving process optimization within GxP regulatory environments.