Job Description

Job Description

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 Takedas 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:

Global GRIDS Strategy Development and Realization:

• 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.

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 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.

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 Takedas 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.
• 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.

This position is currently classified as hybrid by Takedas Hybrid and Remote Work policy

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

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-term incentive compensation. 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 o, company holidays, and wellbeing 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.

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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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.

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