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

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

Join to apply for the Executive Director, Head, Global Regulatory Information, Data & Systems role at BioSpace.

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.

Job Description

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

In partnership 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 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 roles and responsibilities and ensure clarity and synergy across GRO and other functions. 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 defined and, in partnership with Business Operations, delivers to specified service level agreements. Provide vendor oversight and engagement to ensure process 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 maintain 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 to 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 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.

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.

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.

Location

Boston, MA

U.S. Base Salary Range

$208,200.00 – $327,140.00

Benefits

U.S. employees may be eligible for short‑term and / or long‑term incentives.

Medical, dental, vision insurance.

401(k) plan with company match.

Short‑term and long‑term disability coverage.

Basic life insurance.

Tuition reimbursement program.

Paid volunteer time off.

Company holidays and wellness benefits.

Up to 80 hours of sick time per year (U.S. based employees).

New hires eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud of 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.

Job Details

Worker Type : Employee

Worker Sub‑Type : Regular

Time Type : Full time

Job Exempt : Yes

Hybrid Work : Classified as ‘hybrid’ by Takeda’s Hybrid and Remote Work policy

Legal Note

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

#J-18808-Ljbffr