Takeda · 3 months ago
Executive Director, Head, Global Regulatory Information, Data & Systems
Boston, MA
Full-time
Hybrid
Director/Executive
$208K/yr - $327K/yr
15+ years expTakeda is a leading global biopharmaceutical company, and they are seeking an Executive Director, Head of Global Regulatory Information, Data and Systems. This pivotal role is responsible for developing and implementing a comprehensive strategy to ensure regulatory data integrity and drive efficiency in regulatory systems globally, while mentoring a team of experts and managing vendor relationships.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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
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
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
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
Qualification
Required
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
Experience directly working with Registration Management, Submissions, Submissions Archive, and Publishing technologies, a plus
Proven track record of thought leadership through industry presentations, publications, or other mechanisms, a plus
Benefits
Short-term and/ or long-term incentives
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
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
Pharmaceutical Technology
2026-01-11
2026-01-09
Company data provided by crunchbase