Senior Manager, Regulatory Capability & Data Strategy

Takeda Pharmaceutical Co.; Cambridge (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda Pharmaceutical Co. in Boston, MA, seeks a Senior Manager, Business Capability Analyst to translate regulatory business needs into actionable requirements.

You will guide end-to-end process and data implications, supporting agile delivery across the GRIDS portfolio while ensuring compliant, scalable solutions. You will partner with stakeholders, lead workshops, and shape use cases to deliver regulatory capabilities.

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.
• Technical competencies: 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

Requirements elicitation

Documentation

Management

Agile delivery

Stakeholder management

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva RIM

Job description

Takeda Pharmaceutical Co. in Boston, MA, seeks a Senior Manager, Business Capability Analyst to translate regulatory business needs into actionable requirements.

You will guide end-to-end process and data implications, supporting agile delivery across the GRIDS portfolio while ensuring compliant, scalable solutions. You will partner with stakeholders, lead workshops, and shape use cases to deliver regulatory capabilities.