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Regulatory Chief of Staff, Head Regulatory Process Excellence

Company: Takeda Pharmaceutical
Location: Bernardsville
Posted on: November 23, 2022

Job Description:

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 Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.Join Takeda as a Regulatory Chief of Staff, Head Regulatory Process Excellence - where you will work within the organization to advance the objectives and vision of the Head of Regulatory. You will be a strategic thought partner to the Head of Regulatory and Head of Regulatory Operations with regard to problems, current and future initiatives, strategies, project management and budgets. As part of the Global Regulatory Affairs team, you will report to the Head of Regulatory Operations and Cross-Functional Optimization and ensure project management support and facilitation of the Regulatory Leadership Team with the coordination of the preparation of the meetings and tracking of required actions until completion.How you will contribute:

  • Monitor progress toward Regulatory's KPIs, intervening to ensure that Regulatory is on track to meet or exceed its performance targets. Provide insight in evaluating overall Regulatory performance over time and for future planning
  • Lead and deliver multiple process optimization projects and non-drug projects, such that the business achieves a step change in performance (productivity, efficiency, effectiveness). Work with Sr Leadership to identify key opportunities for cross-functional optimization. You will be hands on and able to contribute both as a leader and as an individual contributor.
  • Manage resourcing, build matrix teams and report project status to stakeholders and Sr. Management
  • Develop and grow relationship with internal and external partners to facilitate ideation of opportunities for optimization, securing organizational sponsorship and to effectively implementation solutions
  • Expertly navigate uncharted territory where no process or precedent exists, while maintaining compliance with internal procedures and industry regulations (GxP)
  • Accountable for ensuring measures for accessing success are implemented and monitored.
  • Engage in strategic discussions and provide recommendations based on analysis with quantifiable opportunities to drive optimizationWhat you bring to Takeda:
    • Bachelor's degree or related experience is required. Scientific or closely -related field preferred; Advanced degree preferred
    • 12+ years of experience in the pharmaceutical/biotechnology industry with direct leadership experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies
    • Senior management experience in R&D operations or related field, leading and influencing senior-level management and key stakeholders
    • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
    • Six sigma, LEAN, and/or PMP certification or equivalent desirable
    • Direct experience in the pharmaceutical industry or related field required
    • Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus
    • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
    • Track record 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.
    • Health care business acumen with a comprehensive understanding of the pharmaceutical industryWhat Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.Base Salary Range: $194,600 to $278,000, based on candidate professional experience level. - Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. - - -No Phone Calls or Recruiters Please.#LI-LC1EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Newark , Regulatory Chief of Staff, Head Regulatory Process Excellence, Other , Bernardsville, New Jersey

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