Head of Global Regulatory Operations

2 days ago

Boston, Massachusetts, United States Takeda Pharmaceutical Full time
Job Description

The Head of Global Regulatory Operations will be responsible for developing and implementing the global regulatory affairs strategy to achieve a best-in-class regulatory operations organization.

Key Responsibilities:
  • Be a strategic thought partner to the Head of Regulatory Affairs on 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 a 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.
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.
  • Experience managing complex global partnerships and innovation ecosystems.
  • Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
Benefits:
  • Competitive salary range: $252,000.00 - $396,000.00.
  • Eligibility for short-term and/or long-term incentives.
  • 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.
  • Up to 80 hours of sick time per calendar year.
  • Up to 120 hours of paid vacation.
Equal Employment Opportunity:

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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