Talent.com
Senior Director, Regulatory Data & Systems Strategy

Senior Director, Regulatory Data & Systems Strategy

Takeda PharmaceuticalsBoston, MA, US
9 days ago
Job type
  • Full-time
Job description

Head Of Regulatory Data & Systems Strategy

Reporting to the Head, Global Regulatory Information, Data & Systems, the Head of Regulatory Data & Systems Strategy will be responsible for leading the business systems owners, data governance, and data-related enhancements to support Takeda's regulatory systems.

The Head will be responsible for coordinating regulatory business systems, defining an innovative vision and roadmap, identifying areas for data and capability enhancement, and implementing such initiatives in partnership with R&D DD&T. Further, the Head will be expected to collaborate cross-functionally with business and technical stakeholders, drive partnership with Regulatory Business Operations to drive business prioritization and then work closely with Takeda's DD&T teams for execution.

Accountabilities :

  • Drive the future state vision of regulatory systems at Takeda
  • Collaborate with business process teams, functional SMEs, and others to identify opportunities to enhance regulatory data management
  • Work closely with major platform vendors to understand future state-roadmaps to define opportunities for platform and technology development
  • Leverage inputs from business processes, reporting / analytics, user feedback and other areas to identify areas of continuous improvement
  • Execute data and capability development roadmaps, manage timelines and budget, and collaborate with cross-functional teams to support implementation of enhancements
  • Line management responsibility for up to 10 direct reports

Qualifications :

Educational Qualifications :

  • Minimum BS with 15+ years of experience in Life Sciences or Life Sciences consulting, with a focus on Regulatory preferred
  • Minimum 10+ years of experience with R&D data management, system development, or related experience
  • Regulatory Qualifications :

  • Knowledge of regulatory / quality systems relevant to drug development
  • Prior experience with developing and implementing data management enhancements
  • Demonstrates strong skills with increasing independence in regulatory, program management, and technology development, such as understanding broad concepts within regulatory data and implications across the organization and globally; proactively identifies data issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Ability to assess and adapt to the industry's changing regulations, technology landscape, incorporating learnings into Takeda's regulatory information management vision
  • Prior experience in leading implementations, working with cross-functional teams, and balancing a technology-forward mindset with business stakeholder needs and requirements
  • Interpersonal Skills :

  • Prior experience standing up and leading teams (minimum 5 years of management experience)
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Must work well with others and within global teams
  • Able to bring working teams together for common objectives.
  • 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.

    Create a job alert for this search

    Director Data Strategy • Boston, MA, US

    Related jobs
    • Promoted
    Senior Director of Data Analytics

    Senior Director of Data Analytics

    VirtualVocationsLowell, Massachusetts, United States
    Full-time
    A company is looking for a Senior Director, Data Analytics & Business Intelligence.Key Responsibilities Define and execute the enterprise analytics and BI strategy aligned with business objective...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Regulatory Affairs

    Senior Director, Regulatory Affairs

    eGenesisCambridge, MA, US
    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...Show moreLast updated: 16 days ago
    • Promoted
    Senior Director, Regulatory Data & Systems Strategy

    Senior Director, Regulatory Data & Systems Strategy

    Takeda PharmaceuticalBoston, MA, United States
    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 th...Show moreLast updated: 4 days ago
    • Promoted
    Director of Regulatory Implementation

    Director of Regulatory Implementation

    VirtualVocationsDorchester, Massachusetts, United States
    Full-time
    A company is looking for a Director of Regulatory Implementation.Key Responsibilities Directs the regulatory implementation program and manages a portfolio of 50+ implementation projects Develop...Show moreLast updated: 6 days ago
    • Promoted
    Senior Director, Regulatory Data & Systems Strategy

    Senior Director, Regulatory Data & Systems Strategy

    TakedaBoston, MA, United States
    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 Tak...Show moreLast updated: 8 days ago
    • Promoted
    • New!
    US Regulatory Intelligence Director

    US Regulatory Intelligence Director

    VirtualVocationsLowell, Massachusetts, United States
    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 intell...Show moreLast updated: 17 hours ago
    • Promoted
    Senior Director, Regulatory Strategy Consulting

    Senior Director, Regulatory Strategy Consulting

    Halloran Consulting GroupBoston, MA, United States
    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...Show moreLast updated: 28 days ago
    • Promoted
    Senior Director / Director of Regulatory Affairs

    Senior Director / Director of Regulatory Affairs

    Redefine Your Future with TransMedicsAndover, MA, US
    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...Show moreLast updated: 30+ days ago
    • Promoted
    Executive Director, Head, Global Regulatory Information, Data & Systems

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

    Takeda PharmaceuticalsBoston, MA, US
    Full-time
    Head Of Global Regulatory Information, Data And Systems.Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS) is responsible...Show moreLast updated: 9 days ago
    • Promoted
    Executive Director, Head, Global Regulatory Information, Data & Systems

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

    BioSpaceBoston, MA, United States
    Full-time
    Executive Director, Head, Global Regulatory Information, Data & Systems.Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS...Show moreLast updated: 4 days ago
    • Promoted
    Director, Regulatory Affairs - Strategy

    Director, Regulatory Affairs - Strategy

    Lantheus BrandBedford, MA, US
    Full-time
    Director, Regulatory Affairs - Strategy.Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering t...Show moreLast updated: 30+ days ago
    • Promoted
    Sr. Director, Regulatory Affairs

    Sr. Director, Regulatory Affairs

    Akebia TherapeuticsCambridge, MA, United States
    Full-time
    Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of e...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director Global Regulatory Affairs – Global Regulatory Lead – Neuroscience

    Senior Director Global Regulatory Affairs – Global Regulatory Lead – Neuroscience

    Takeda PharmaceuticalBoston, MA, United States
    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 th...Show moreLast updated: 4 days ago
    • Promoted
    Executive Director, Head, Global Regulatory Information, Data & Systems

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

    TakedaBoston, MA, United States
    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...Show moreLast updated: 8 days ago
    • Promoted
    • New!
    Senior Director Global Regulatory Affairs - Global Regulatory Lead - Neuroscience

    Senior Director Global Regulatory Affairs - Global Regulatory Lead - Neuroscience

    Takeda PharmaceuticalBoston, MA, US
    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...Show moreLast updated: 11 hours ago
    • Promoted
    Senior Director, Regulatory Affairs CMC Policy and Advocacy

    Senior Director, Regulatory Affairs CMC Policy and Advocacy

    Alnylam PharmaceuticalsCambridge, MA, United States
    Full-time
    The Senior Director, Regulatory Affairs CMC Policy and Advocacy will lead the development and implementation of global regulatory advocacy strategies. This role will also oversee global regulatory C...Show moreLast updated: 11 days ago
    • Promoted
    Senior Manager / Associate Director, Regulatory Strategy

    Senior Manager / Associate Director, Regulatory Strategy

    EyePointWatertown, MA, US
    Full-time
    Be Seen And Heard At Eyepoint Pharmaceuticals.At EyePoint, leadership trusts our employees to get the job done.The patient-centric and award-winning approach we're taking in business fuels our succ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Olema OncologyBoston, MA, United States
    Full-time
    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs at Olema Oncology.Reports to the Senior Vice President of Regulatory Affairs. Location : Boston, MA or San Francisco, CA.Domestic...Show moreLast updated: 18 days ago