Executive Director, Head, Global Regulatory Information, Data & Systems

Role Summary

Executive Director, Head, Global Regulatory Information, Data & Systems (GRIDS) at Takeda. Reporting to the Head of Global Regulatory Operations, this role is responsible for developing and implementing a comprehensive GRIDS strategy to ensure regulatory data integrity and drive adoption and efficiency of Regulatory systems globally. The role includes guiding and mentoring a team, improving regulatory data quality, achieving global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs, R&D, and the enterprise. It also leads accurate and timely reporting for both common and ad hoc regulatory affairs questions. Location: Boston, MA.

Responsibilities

• Develop and align global GRIDS strategy and roadmap in partnership with GRA and GRO leadership, Takeda IT, R&D, and enterprise stakeholders.
• Execute and track the GRIDS strategy with milestones, deliverables, activities, and metrics; proactively identify and manage risks and issues; maintain stakeholder engagement.
• Structure and align the internal GRIDS team, define roles and responsibilities, and ensure cross-functional clarity and collaboration.
• Mentor direct reports and oversee vendor support to ensure SLAs are met and processes are clear and adopted.
• Establish robust regulatory data governance and stewardship, ensure data quality for authoritative sources, and drive remediation as needed.
• Lead adoption of regulatory information standards (eCTD4, SPOR/IDMP, CTIS/EU CTR) and ensure organizational readiness.
• Oversee master data management for regulatory data and connect with RD and enterprise systems.
• Drive GRIDS data analytics, BI, and visualization to support data-driven decision making for TAUs, regulatory leadership, and other stakeholders; provide standard and ad-hoc regulatory reports.
• Partner with Takeda IT to evolve and integrate GRIDS systems, translate business requirements into system functionality, and support release management and data migration.
• Collaborate with GRA, regional teams, and LOCs to drive system adoption and utilization.

Qualifications

• Minimum Bachelor's Degree; MS preferred.
• 15+ years of experience in life sciences, particularly in Regulatory Affairs and Regulatory Information, Data and Systems.
• Experience leading global Regulatory Information, Data and Systems capabilities and teams.
• Credibility engaging at senior levels for developing and aligning GRIDS strategy.
• Ability to conduct strategic discussions with Regulatory, R&D, and enterprise stakeholders on information management processes and systems.
• Experience designing and implementing RIM digital transformation and innovating across processes and technology solutions.
• Experience with regulatory processes and technology for document authoring, publishing/validation/viewing, registration and commitment tracking, and archiving.
• Experience with regulatory data standards (e.g., xEVMPD, IDMP); understanding of the R&D value chain and data taxonomy integration.
• Understanding of global drug development and regulatory processes; experience with Veeva RIM platform for health authority registration management.
• Experience with Registration Management, Submissions, Submissions Archive, and Publishing technologies (a plus).
• Proven thought leadership through industry presentations, publications, or similar (a plus).

Skills

• Strategy Development
• Influential Communication
• Collaborative Leadership
• Innovative Thinking
• Results Orientation
• Analytical Skills

Education

• Minimum Bachelor's Degree; MS preferred.