Executive Director, Head, Global Regulatory Information, Data & Systems (BOSTON)
Company: Takeda Pharmaceutical
Location: Boston
Posted on: March 25, 2026
|
|
|
Job Description:
By clicking the “Apply” button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda’s Privacy Notice and Terms of Use. I further attest
that all information I submit in my employment application is true
to the best of my knowledge. 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 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. 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 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 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 Takeda’s 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 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. 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
Keywords: Takeda Pharmaceutical, Boston , Executive Director, Head, Global Regulatory Information, Data & Systems (BOSTON), IT / Software / Systems , Boston, Massachusetts
