Executive Director, Head, Global Regulatory Information, Data & Systems jobs in United States
cer-icon
Apply on Employer Site
company-logo

Takeda · 21 hours ago

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

Takeda is a leading global biopharmaceutical company, and they are seeking an Executive Director to lead their Global Regulatory Information, Data and Systems strategy. This pivotal role involves ensuring regulatory data integrity, driving system adoption, and enhancing efficiency across Global Regulatory Affairs and Research & Development.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Develop and align global GRIDS strategy and roadmap in partnership with GRA and GRO leadership
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
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
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

Qualification

Regulatory AffairsData GovernanceRIM Digital TransformationVeeva RIM PlatformData AnalyticsRegulatory Data StandardsGlobal Drug DevelopmentAnalytical SkillsCollaborative LeaderInfluential CommunicatorInnovative ThinkerResults-Oriented

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

U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Company

Takeda

twittertwittertwitter
company-logo
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.

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 Company
Total Funding
$2.46B
2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M

Leadership Team

leader-logo
Christophe Weber
President and CEO
linkedin
leader-logo
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
linkedin
Company data provided by crunchbase