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Regulatory Information Management and Innovation Lead

Takeda Pharmaceutical - Harwick, PA

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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 in order to bring life-changing therapies to patients worldwide.Join Takeda as a Regulatory Information Management and Innovation Lead where you will formulate and implement the Global Regulatory Affairs vision, strategy, and tactics to achieve a best-in-class Regulatory Information Management / Digital operating model. You will also implement high-performing business partnerships with tech and strategic sourcing partners. As part of the Global Regulatory Affairs team, you will report to the Head of Regulatory Operations and Cross-Functional Optimization and influence and drive external regulatory standards through strategic partnerships with regulators, trade groups, and tech / BPO vendors.How you will contribute:Envision and implement a digital innovation ecosystem across GRA, R&D, and the enterpriseAchieve 1 - 2 regulatory information management innovations per year that drive operational excellence, compliance, or enhanced digital insights.Partner with senior leaders in R&D and IT to envision and establish a robotic process automation factory operating model.Drive strategic approaches and business operating models with tech and sourcing partners that result in new digital tools, approaches, and revenue streams.Act as an internal regulatory information management / digital evangelist or champion across GRA and the enterprise.Partner and lead the effort to connect the digital / information management supply chain across R&D and the enterprise.Drive a culture of continuous experimentation and improvement through the use of the innovation strategic sourcing ecosystem.Minimum Requirements/Qualifications:Bachelor''s degree or related experience is required. Scientific or closely -related field preferred; Advanced degree a plus15+ years of experience in or supporting the pharmaceutical/biotechnology industry with direct leadership experience in regulatory information managementSenior management experience in regulatory information management / digital, leading and influencing senior-level management and key stakeholdersProven track record of driving innovation and creating value in the regulatory information management / digital domain.Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverablesExperience overseeing global and complex business relationships with business partnersDirect experience in the pharmaceutical industry or related field requiredPrevious experience leading a medium to large global 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.Track record of effective leadership of a diverse set of internal / external stakeholders.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.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

Created: 2025-09-06

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