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

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OBJECTIVES/

PURPOSE:

Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS) is responsible for developing and implementing a comprehensive GRIDS strategy. This pivotal role ensures Takeda’s regulatory data integrity while driving the adoption and efficiency of Regulatory systems globally.

This role involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the enterprise. Additionally, the role leads accurate and timely reporting for both common and ad hoc regulatory affairs questions.

ACCOUNTABILITIES:

Global GRIDS Strategy Development and Realization:

• In partnership and collaboration 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 agreed to set of milestones, key deliverables, activities, and monitor progress through metrics. Proactively identify and manage risks and issues. Ensure ongoing stakeholder engagement and awareness throughout.
• Align and structure internal GRIDS team to enable strategy realization and deliverables. Define team roles and responsibilities and ensure alignment across GRO and other functions to ensure clarity and synergy. Develop and implement team norms and ways of working, driving delivery focus and prioritization.
• Actively mentor and guide direct reports in the execution of deliverables.
• Ensure external vendor support for GRIDS activities is clearly defined and, in partnership with Business Operations team, is delivering to specified service level agreements. Actively provide vendor oversight and engage with vendor(s) to ensure process and ways-of-working clarity and adoption.

Data Governance and Sustainability:

• Establish robust regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources. Proactively drive data remediation efforts as needed to ensure high data quality.
• Lead initiatives for regulatory information standards adoption and ensure organizational readiness to meet regulatory requirements, including eCTD4, SPOR/IDMP, and CTIS/EU CTR.
• Oversee master data management for regulatory data and partner/ drive connectivity with RD and enterprise systems.

GRIDS Data Analytics:

• Drive GRIDS business intelligence and data visualization capabilities to support data-driven decision making for Therapeutic Areas Units (TAUs), regulatory leadership, and other stakeholders for pipeline realization and post-approval lifecycle management.
• Provide standard regulatory reports and dashboards and produce ad-hoc and custom regulatory reports as requested.

GRIDS System Business Ownership:

• Partner with Takeda IT functions to drive the evolution, interoperability, data sharing, and integration of Takeda’s global GRIDS systems.
• Ensure business requirements are identified and adequately translated into system and supporting business process functionality.
• Support system release management, data migration and validation activities.
• Collaborate with GRA functions, regions, and local operating companies (LOCs) to drive system adoption and utilization.

CORE COMPETENCIES:

• Strategy Development: Ability to create and implement long-term GRIDS strategies with a forward-thinking approach.
• Influential Communicator: Exceptional communication skills to articulate complex regulatory data concepts effectively.
• Collaborative Leader: Strong leadership qualities to guide cross-functional teams and drive organizational change.
• Innovative Thinker: Proactive in embracing innovation and…