Head of Global Regulatory Affairs

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Company: Takeda Pharmaceuticals
Location: Boston, MA

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Job Description

The Head of Global Regulatory Affairs is a critical function at Takeda. Based in Boston, this leader will report to the Head, Regulatory, Global Patient Safety Evaluation (GPSE) & Development Operations.


OBJECTIVES

  • Function as the inspirational leader of the Global Regulatory Affairs (GRA) organization developing a organization of highly engaged and talented individuals recognized within and outside of Takeda
  • Lead, integrate and manage the regulatory global development organization with staff based in regional organizations/locations (EU, US, Asia, Japan), including regulatory affairs staff based within local operating companies (LOCs).
  • Oversee the overall regulatory inputs to Takeda’s development program ensuring a progressive regulatory strategy approach for all products from early development through the transition to mature products.
  • Creating shared accountability across the entire GRA community while also enabling LOC empowerment in support of Therapeutic Area Units and Business Units
  • Define the global organization structure including Strategy, CMC, Labeling and Operations functions, and develop efficient global resourcing plans.
  • Serve as a single point of accountability/contact for the overall global regulatory organization.
  • Coordinate regulatory intelligence across regions and provide oversight to regions for successful interactions/ outcomes with regional regulatory agencies. Interact directly with regulatory agencies for critical issues.
  • Ensures organization develops and drives global regulatory strategies, processes, standards and systems that maximize efficiencies and minimize complexity and risk to filings/approvals/changes.
  • Represent Takeda on regulatory issues/topics at high level internal meetings as well as external regulators, industry groups and other key contacts.


SCOPE

As a key leader at Takeda, the Head of Global Regulatory Affairs will have 8-12 direct report and a global team of indirect reports ranging 300-400 colleagues.


ACCOUNTABILITES

  • Provide leadership to the following regulatory groups: Global Therapeutic Area Strategy, MPG, Regional, Labeling, CMC, and Operations
  • Ensure development of progressive global regulatory strategies that meet regional requirement and reflect changes in the external environment and industry best practice.
  • Effectively lead the substantive, operational and administrative aspects of the Global Regulatory Affairs organization to maximize business opportunities including financial management, leadership and organization development, talent management, external outreach and partner/stakeholder management
  • Ensure effective regulatory support of global development and global product/project teams. Refine/develop project/product global regulatory strategy document with input from regional leads, CMC and labeling groups.
  • Provide leadership to enable thorough vetting, influencing and challenging of the regulatory strategies through a collaborative process with Therapeutic Area Unit leadership to ensure alignment with the goals and objectives of the R&D organization.
  • Implement tools and processes for tracking and management of registrations, regulatory interactions and commitments for all regulatory activities performed by Takeda (including local operating companies).
  • Assess impact of new data, feedback from regulatory agencies and changes in regulatory landscapes on Takeda’s regulatory strategy.
  • Provide regulatory leadership and advise on regulatory guidelines, policy, product specific regulatory issues and the regulatory climate.
  • Support the development of regulatory strategy and appropriate execution of all Health Authority interactions globally. Provide leadership for preparation of business critical Health Authority meetings globally
  • Develop RA functional strategies including MRP and annual plans.
  • Develop plan for organizational efficiencies by coordination of global RA resources.
  • Establish/refine and support RA best practices and processes.
  • Convene external Global Regulatory Advisory Board meetings that include experts with knowledge/ experience in regulatory intelligence and ensure that Takeda effectively responds to global, regional and therapeutic challenges.
  • Contribute to creating and communicating an employment culture and values which attract, retain and develop the most effective people at all levels to maximize their potential contributions to the business.
  • Ensure availability of training and education programs to support achievement of strategic goals, high quality performance and personnel development.
  • Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice including good clinical practice, data privacy and ethical standards.


DIMENSIONS & ASPECTS

Technical & Functional Expertise:

  • Extensive, advanced knowledge of global and local regulatory agency requirements.
  • Ability to comprehend and synthesize complex data, identify issues and trends and develop and implement solutions/plans.
  • Knowledge and experience in identification, analysis and implementation of programs and procedures required to achieve corporate objectives.
  • Global regulatory expertise with demonstrated strong ability for collaboration and team leadership; experience leading and working with cross-cultural teams.

Leadership:

  • Strong leadership capability with developed skills in team building, motivating and developing people.
  • Excellent communicator with strong written and presentation skills.
  • Ability to influence and work effectively with various partners, regions and cultures.
  • Enterprise level leadership with the ability to inspire, motivate and drive results.
  • Proven skills as an effective team player who can engender credibility and confidence within and outside the company.
  • Ability to distil complex issues and ideas down to simple comprehensible terms.
  • Executive leadership presence and confidence.
  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.

Interaction:

  • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace.
  • Ability to effectively implement R&D’s partnership strategy.
  • Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner.
  • Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions.

Innovation:

  • Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation.
  • Comfortable challenging the status quo and bringing forward innovative solutions.
  • Ability to take risks implementing innovative solutions, accelerating time to market.

Complexity:

  • Ability to work in a global ecosystem (internal and external) with a high degree of complexity.
  • Breadth of knowledge required across therapeutic areas, indications, and/or modalities.


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • Minimum BS degree; advanced degree (MS, MBA, PhD or MD) preferred
  • 15+ years applicable experience including at least 10 years global experience within Pharmaceutical Research and Development and at least 7 years in Regulatory.
  • Substantial pharmaceutical industry or Health Authority experience globally and supported by business and technical acumen required.
  • Significant experience in the development and execution of regulatory strategies, the drug development process, regulatory compliance, regulatory support for product lifecycle management and establishing productive working relationships with Health Authorities’ decision makers.
  • Proven experience managing regulatory groups in different regions and a strong understanding of different cultural practices.
  • Experience operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.
  • Demonstrated ability to provide strategic leadership of a global function.


Locations

Boston, MA


Worker Type

Employee


Worker Sub-Type

Regular


Time Type

Full time

Job ID R0014721