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

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

TakedaBoston, MA, United States
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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

  • Develop and align global GRIDS strategy and roadmap in partnership with GRA and GRO leadership, Takeda IT functions, R&D cross-functional, and enterprise stakeholders.
  • Execute and track GRIDS strategy through agreed to set of milestones, key deliverables, activities, and monitor progress through metrics.
  • Align and structure internal GRIDS team to enable strategy realization and deliverables.
  • Actively mentor and guide direct reports in the execution of deliverables.
  • Ensure external vendor support for GRIDS activities is clearly defined and delivering to specified service level agreements.

Data Governance and Sustainability

  • Establish robust regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources.
  • Lead initiatives for regulatory information standards adoption and ensure organizational readiness to meet regulatory requirements.
  • Oversee master data management for regulatory data and partner with / 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.
  • 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 leveraging technology to enhance RIM processes.
  • Results-Oriented : Focused on achieving measurable outcomes and driving continuous improvement.
  • Analytical Skills : Strong analytical skills to interpret regulatory data and deliver insightful reports and visualizations.

    • Qualifications

  • Minimum Bachelor's Degree, MS preferred;
  • 15+ years of experience in the life sciences, particularly in Regulatory Affairs and Regulatory Information, Data and Systems.
  • Experience in leading global Regulatory Information, Data and Systems capabilities and teams.
  • Credibility and experience engaging at senior levels for the development and alignment of GRIDS strategy.
  • Ability to hold strategic conversations with Regulatory, R&D, and enterprise stakeholders regarding global Information Management processes and systems and the regulatory applications and their use within Regulatory execution.
  • Demonstrated experience in designing and implementing RIM digital transformation with proven ability to innovate across business processes and technology solutions.
  • Experience with regulatory processes and technology for submission document authoring, submission publishing / validation / viewing, registration and commitment tracking, and regulatory document archiving.
  • Experience with regulatory data standards, such as xEVMPD and IDMP.
  • Deep understanding of the entire R&D value chain, particularly data taxonomies and domain integration.
  • Understanding of global drug development & regulatory processes.
  • Experience with Veeva RIM platform for health authority registration management.

    • Takeda Compensation and Benefits Summary

    We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

    For Location : Boston, MA

    U.S. Base Salary Range : $208,200.00 - $327,140.00

    EEO Statement

    Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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    Director Regulatory • Boston, MA, United States

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