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EUCAN Regulatory Affairs Manager, Oncology

Company: Takeda Pharmaceutical
Location: Newark
Posted on: November 22, 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 DescriptionAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as -a EUCAN Regulatory Affairs Manager, Oncology, based -in Zurich. Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVE:

  • Provides regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements, in order to enable patient access to meaningful medicines.
  • Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
  • Provides regulatory expertise and strategic focus for assigned development projects
  • As Regional Lead, may be called upon to act as deputy to the Global Regulatory lead, attending internal leadership team meetings, as appropriate
  • Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements
  • For centraised products may be primary EMA contact for project(s)/products of responsibility. Informs the business. May manages interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the Europe Union and European Economic Area for specific products.ACCOUNTABILITIES:
    • Leads the regulatory working team for own region and may represents region as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan
    • Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
    • For the project(s)/product(s) of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
    • Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region (s) of responsibility (E.g. EMA submissions for Europe). Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
    • Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned project(s) of responsibility.
    • Authors and reviews regional regulatory strategies as well as executes day-to-day activitiesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
      • BS degree or equivalent in science; advanced degree preferred
      • Experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases.
      • Sound working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in the EU).
      • A good understanding of basic regulatory requirements in emerging markets is a plus.
      • Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
      • Proven regulatory submissions capability in a region basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. ---
      • Able to demonstrate skill(s) in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization.
      • Generally strong in working well with others and within global teams.
      • Able to bring working teams together for common objectives.TRAVEL REQUIREMENTS:
        • Willingness to travel to various meetings, including overnight trips.
        • Requires approximately up to 10-30% travel.WHAT TAKEDA CAN OFFER YOUAt Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.Empowering Our People to ShineDiscover more at takedajobs.comAt our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have? LocationsZurich, SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Newark , EUCAN Regulatory Affairs Manager, Oncology, Executive , Newark, New Jersey

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