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

Takeda • Boston, MA

86d • $208,200 - $327,140

About The Position

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.

Requirements

• 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.
• Demonstrated experience in designing and implementing RIM digital transformation.
• 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.

Nice To Haves

• Experience directly working with Registration Management, Submissions, Submissions Archive, and Publishing technologies.
• Proven track record of thought leadership through industry presentations, publications, or other mechanisms.

Responsibilities

• 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 milestones, key deliverables, activities, and monitor progress through metrics.
• Proactively identify and manage risks and issues, ensuring ongoing stakeholder engagement and awareness.
• 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.
• Develop and implement team norms and ways of working, driving delivery focus and prioritization.
• 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.
• Establish robust regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources.
• 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.
• Drive GRIDS business intelligence and data visualization capabilities to support data-driven decision making.
• Provide standard regulatory reports and dashboards and produce ad-hoc and custom regulatory reports as requested.
• Partner with Takeda IT functions to drive the evolution, interoperability, data sharing, and integration of Takeda’s global GRIDS systems.

Benefits

• Medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• Accrual of up to 120 hours of paid vacation for new hires.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees