Regulatory Chief of Staff, Head Regulatory Process Excellence

Company: Takeda Pharmaceutical
Location: Nazareth
Posted on: May 27, 2023

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 planningLead 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. ManagementDevelop and grow relationship with internal and external partners to facilitate ideation of opportunities for optimization, securing organizational sponsorship and to effectively implementation solutionsExpertly 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 preferred12+ 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 suppliesSenior management experience in R&D operations or related field, leading and influencing senior-level management and key stakeholdersProven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverablesSix sigma, LEAN, and/or PMP certification or equivalent desirableDirect experience in the pharmaceutical industry or related field requiredPrevious experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plusProven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverablesTrack 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 VisionFinancial Planning & Stability: 401(k) with company match and Annual Retirement Contribution PlanHealth & Wellness programs including onsite flu shots and health screeningsGenerous time off for vacation and the option to purchase additional vacation daysCommunity Outreach Programs and company match of charitable contributionsFamily Planning SupportFlexible Work PathsTuition 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 accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.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

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