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

Role Summary

Executive Director, Head, Global Regulatory Information, Data & Systems (GRIDS) is responsible for developing and implementing a comprehensive GRIDS strategy to ensure regulatory data integrity and drive adoption and efficiency of Regulatory systems globally. This role involves guiding and mentoring a team, driving regulatory data quality, ensuring global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs, Research & Development, and the enterprise. The role also leads accurate and timely reporting for both common and ad hoc regulatory affairs questions.

Responsibilities

• In partnership with GRA and GRO leadership, Takeda IT functions, R&D cross-functional, and enterprise stakeholders, develop and align global GRIDS strategy and roadmap.
• Execute and track GRIDS strategy through milestones and deliverables, monitor progress with metrics, identify and manage risks, and maintain stakeholder engagement.
• Align and structure internal GRIDS team, define roles, ensure cross-functional alignment, and establish operating norms to drive delivery and prioritization.
• Mentor direct reports in the execution of deliverables.
• Ensure external vendor support for GRIDS activities meets service level agreements with vendor oversight and clear adoption of processes.

Data Governance and Sustainability

• Establish robust regulatory data governance and stewardship, ensure data quality for authoritative data sources, and drive remediation as needed.
• Lead initiatives for regulatory information standards adoption and readiness to meet regulatory requirements (eCTD4, SPOR/IDMP, CTIS/EU CTR).
• Oversee master data management for regulatory data and connect with RD and enterprise systems.

GRIDS Data Analytics

• Drive GRIDS BI and data visualization to support data-driven decision making for TAUs, regulatory leadership, and other stakeholders for pipeline realization and post-approval lifecycle management.
• Provide standard regulatory reports and dashboards and produce ad-hoc/custom regulatory reports as requested.

GRIDS System Business Ownership

• Partner with Takeda IT to evolve interoperability, data sharing, and integration of global GRIDS systems.
• Translate business requirements into system functionality and supporting processes.
• Support system release management, data migration, and validation activities.
• Collaborate with GRA functions, regions, and LOCs to drive system adoption and utilization.

Qualifications

• Minimum Bachelor's Degree, MS preferred
• 15+ years in life sciences, particularly 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 GRIDS strategy development and alignment
• Ability to conduct strategic conversations with Regulatory, R&D, and enterprise stakeholders on Information Management processes and regulatory applications
• Experience designing and implementing RIM digital transformation with innovation across processes and technology
• Experience with regulatory processes and technology for submission document authoring, publishing/validation/viewing, registration and commitment tracking, and archival
• Experience with regulatory data standards such as xEVMPD and IDMP
• Understanding of the full R&D value chain, data taxonomies, and domain 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 is a plus

Education

• Minimum Bachelor's Degree; MS preferred

Additional Requirements

• Hybrid work policy applies