Talent.com
serp_jobs.error_messages.no_longer_accepting
Executive Director, Head, Global Regulatory Information, Data & Systems

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

Takeda PharmaceuticalBOSTON, MA, United States
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.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 e mployee s may be eligible for s hort - t erm and / or l ong- t erm incentive s . 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

    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.

    serp_jobs.job_alerts.create_a_job

    Director Regulatory • BOSTON, MA, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Senior Director, Regulatory Affairs

    Senior Director, Regulatory Affairs

    eGenesisCambridge, MA, US
    serp_jobs.job_card.full_time
    Senior Director, Regulatory Affairs.Reporting to the Senior Vice President of Development and based in our Cambridge, MA office, the Director / Senior Director of Regulatory Affairs is responsible fo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director of Regulatory Affairs

    Director of Regulatory Affairs

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Regulatory Affairs, Dx / CDx and Medical Devices.Key Responsibilities Develop and implement regulatory strategies for diagnostics and medical devices to support...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Regulatory Site CMC

    Director, Regulatory Site CMC

    Takeda PharmaceuticalsBoston, MA, US
    serp_jobs.job_card.full_time
    At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and oth...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Utility Regulatory Director

    Utility Regulatory Director

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Utility Regulatory Support.Key Responsibilities Act as a steward of regulatory relationships, processes, and deliverables Research and apply findings across ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Director / Director of Regulatory Affairs

    Senior Director / Director of Regulatory Affairs

    Redefine Your Future with TransMedicsAndover, MA, US
    serp_jobs.job_card.full_time
    Senior Director / Director of Regulatory Affairs.TransMedics' pioneering Organ Care System (OCS) was developed to address the major limitations of the current standard of care, cold storage, by prese...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    External Innovation Executive Director

    External Innovation Executive Director

    Vertex Pharmaceuticals (San Diego) LLCBoston, MA, United States
    serp_jobs.job_card.full_time
    The External Innovation (EI) Executive Director leads end‑to‑end identification, evaluation, and advancement of external opportunities that materially strengthen Vertex’s R&D pipeline across modali...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Director, Regulatory Strategy Consulting

    Senior Director, Regulatory Strategy Consulting

    Halloran Consulting GroupBoston, MA, United States
    serp_jobs.job_card.full_time
    Career Opportunities with Halloran Consulting Group.Senior Director, Regulatory Strategy Consulting.Are you looking for a company that is committed to improving human health, and a role that will d...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Regulatory Affairs Director, Global Regulatory Strategy

    Regulatory Affairs Director, Global Regulatory Strategy

    AstraZenecaJamaica Plain, MA, US
    serp_jobs.job_card.full_time
    Regulatory Affairs Director, Global Regulatory Strategy.The Regulatory Affairs Director, Global Regulatory Strategy will be responsible for the development and implementation of global regulatory s...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Regulatory Affairs, Regulatory Science & Execution

    Director, Regulatory Affairs, Regulatory Science & Execution

    Alexion PharmaceuticalsBoston, MA, US
    serp_jobs.job_card.full_time
    Regulatory Affairs Director (RAD).The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation, and maintenance of regulatory strate...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director, Global Regulatory Affairs - GI & Inflammation

    Associate Director, Global Regulatory Affairs - GI & Inflammation

    Takeda PharmaceuticalCambridge, MA, US
    serp_jobs.job_card.full_time
    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 Taked...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    US Regulatory Policy Director

    US Regulatory Policy Director

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, US Regulatory Intelligence & Policy Lead.Key Responsibilities : Lead the acquisition, analysis, communication, and knowledge management of US regulatory in...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Regulatory Compliance Director

    Regulatory Compliance Director

    Dana-Farber Cancer InstituteBrookline, MA, United States
    serp_jobs.job_card.full_time
    Regulatory Compliance Director.Compliance team, collaborating across all areas of the organization with a focus on creating a culture of trust and ethical conduct and promoting detection and preven...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Intelligence - Global Regulatory Liaison Office, Vice President,

    Regulatory Intelligence - Global Regulatory Liaison Office, Vice President,

    State StreetBoston, MA, US
    serp_jobs.job_card.full_time
    Global Regulatory Liaison Office.We are seeking to recruit an enthusiastic and motivated professional, to join our Global Regulatory Liaison Office. The candidate will play a vital role in the manag...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Executive Director, Head, Global Regulatory Information, Data & Systems

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

    TakedaBoston, MA, United States
    serp_jobs.job_card.full_time
    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 s...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Regulatory Affairs, Regulatory Science & Execution

    Director, Regulatory Affairs, Regulatory Science & Execution

    AstraZenecaBoston, MA, US
    serp_jobs.job_card.full_time
    Director Of Regulatory Affairs Strategy & Execution.Lead the future of regulatory strategy for rare diseases! Are you a strategic regulatory leader ready to shape the development and lifecycle of ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director, Global Regulatory Affairs

    Associate Director, Global Regulatory Affairs

    Takeda PharmaceuticalCambridge, MA, US
    serp_jobs.job_card.full_time
    By clicking the Apply button, I understand that my employment application process with Takeda will commence and that.I provide in my application will be processed in line with.I further attest that...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Executive Director Technology Solutions Leader

    Executive Director Technology Solutions Leader

    BMC SoftwareBoston, MA, US
    serp_jobs.job_card.full_time
    Executive Director, Technology Solutions Leader.The Executive Director, Technology Solutions Leader is a senior level role responsible for developing Boston Medical Center Health System (BMCHS) ext...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director - Analytics, Global Regulatory Affairs

    Associate Director - Analytics, Global Regulatory Affairs

    TakedaBoston, MA, United States
    serp_jobs.job_card.full_time
    Associate Director - Analytics, Global Regulatory Affairs.Location : Massachusetts - Virtual.This role involves strategic and operational oversight of custom analytics deliveries from Global Regulat...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Global Regulatory Affairs, Neuroscience

    Director, Global Regulatory Affairs, Neuroscience

    Takeda PharmaceuticalCambridge, MA, US
    serp_jobs.job_card.full_time
    By clicking the Apply button, I understand that my employment application process with Takeda will commence and that.I provide in my application will be processed in line with.I further attest that...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Regulatory Affairs Director, Global Regulatory Strategy

    Regulatory Affairs Director, Global Regulatory Strategy

    Alexion PharmaceuticalsBoston, MA, US
    serp_jobs.job_card.full_time
    Regulatory Affairs Director, Global Regulatory Strategy.The Regulatory Affairs Director, Global Regulatory Strategy will be responsible for the development and implementation of global regulatory s...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30