Head, Global Regulatory Operations

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Job Description

The Head of Regulatory Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a best-in-class Regulatory Operations organization. The role will involve envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the enterprise. Additionally, the role will influence and drive external regulatory standards through strategic partnerships with regulators, trade groups, and technology/BPO vendors.

Key Responsibilities:

• Be a strategic thought partner to the Head of Regulatory about complex problems, current and future initiatives, strategies, and budgets. Look across teams to identify synergies and interdependencies to ensure optimal working model across all regulatory sites/functions.
• Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of the department.
• Monitor progress toward Functional KPIs, intervening as necessary to ensure that the functions are on track to meet or exceed its performance targets. Provide complex analysis and insight in evaluating overall functional performance over time and for future planning.
• Develop and maintain a Regulatory Affairs Quality Management System including a system for providing appropriate worldwide training.
• Build and maintain communication strategy and platform for all staff across the organization.
• Responsible for timely dissemination of regulations, guidelines, and data to Global Regulatory Affairs staff via team sites or intranet.
• Help create and communicate an employment culture and values which attract, retain, and develop the most effective people.
• Ensure conformance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application, and complexity of technical knowledge)

• Comprehensive understanding of the pharmaceutical industry, R&D, and regulatory affairs
• Experience managing complex global partnerships and innovation ecosystems.
• Project-management expertise demonstrated ability to lead complex outsourcing projects.
• Deep understanding of regulatory information management
• Savvy and effective negotiation skills

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

• Ability to lead and inspire a diverse set of internal / eternal partners and stakeholders.
• Demonstrated ability to work across functions, regions, and cultures.
• Functional-level leadership with the ability to inspire, motivate, and drive results.
• Outstanding communicator, able to persuasively convey both ideas and data, verbally and in writing.
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company.
• Ability to distill complex issues and ideas down to simple comprehensible terms.
• Demonstrates senior leadership presence and confidence.
• Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.

Decision-making and Autonomy

• Decision making responsibilities:
  • Provide input to complex decisions that impacts across functional areas.
  • Accountable for decision-making for designated function.
  • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions.
  • Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution.
• Accountable for providing inception of and implementing vision and strategy for designated scope.

Interaction

• Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
• Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
• Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions.
• Expertly navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace.

Innovation

• Strong ability to create and drive and integrated innovation ecosystem across a diverse set of stakeholders.
• Forward thinking with the ability to recommend, influence and implement 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.
• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
• Role models respect and inclusion, creating a culture that fosters innovation.
• Ability to create innovative business models with tech and strategic sourcing partners.

Complexity

• Deep expertise required.
• Ability to see and understand broader, enterprise-level perspective.
• Ability to effectively lead and drive an ecosystem with diverse partners and suppliers.
• Ability to work in a global ecosystem (internal and external) with a high degree of complexity.

Requirements:

Minimum BS degree; advanced degree (MS, MBA, PhD, or MD) preferred with 15+ years of industry experience in and or around drug development with responsibilities for major aspects of strategic planning, implementation, and project management.

Senior management experience in pharmaceutical or related field, leading a medium to large organization and influencing senior-level management and key stakeholders.

Proven record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.

Operational experience in pharmaceutical drug development with significant direct exposure to clinical development

History of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.

Experience managing complex global partnerships and innovation ecosystems.

Health care business acumen with a comprehensive understanding of the pharmaceutical industry

This position is currently classified as “hybrid” in accordance with 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. 

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U.S. Base Salary Range:

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.

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Job Exempt