Regulatory Operations Leadership Professional

3 days ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time

At Takeda Pharmaceutical, we are seeking a highly skilled and experienced Regulatory Operations Leadership Professional to join our team. In this critical role, you will formulate and implement the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve best-in-class regulatory operations.

This position involves envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the enterprise. You will influence and drive external regulatory standards through strategic partnerships with regulators, trade groups, and technology/BPO vendors.

Key Responsibilities
  • To be a strategic thought partner to the Head of Regulatory about complex problems, current and future initiatives, strategies, and budgets.
  • To look across teams to identify synergies and interdependencies to ensure an optimal working model across all regulatory sites/functions.
  • To serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of the department.
  • To monitor progress toward Functional KPIs, intervening as necessary to ensure that the functions are on track to meet or exceed its performance targets.
  • To provide complex analysis and insight in evaluating overall functional performance over time and for future planning.

Required Expertise:

  • 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.
  • Outstanding communicator, able to persuasively convey both ideas and data, verbally and in writing.
  • Demonstrates senior leadership presence and confidence.

Preferred Qualifications:

  • Advanced degree (MS, MBA, PhD, or MD).
  • 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.

The estimated salary range for this position is $120,000 - $180,000 per year, commensurate with experience and qualifications.

Takeda offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) plan, company match, short-term and long-term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants 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.



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