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Senior Manager, EUCAN Regulatory Lead Neuroscience

Company: Takeda Pharmaceutical
Location: Pen Argyl
Posted on: November 25, 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 Senior Manager, EUCAN Regulatory Lead Neuroscience based in Zurich. Here, you will be a vital contributor to our inspiring, bold mission.The Senior Manager, EUCAN Regulatory Lead Neuroscience will be responsible for:

  • Providing strategic and tactical regional regulatory advice and guidance to teams to achieve timely and efficient conduct of development programs while maintaining full compliance with applicable regulatory requirements.
  • Effectively communicating objective assessments of the likelihood of success of these regulatory strategies.
  • Providing regulatory expertise and strategic focus for assigned development projects and /or marketed product life cycle management
  • Monitoring and informing 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
  • Being the primary EMA contact for project(s)/products of responsibility.
  • Informing the business and manages interactions with EMA and national health authorities and HTAs (jointly with value and access team in in context of parallel consultation) in the Europe Union and European Economic Area for specific product(s).ACCOUNTABILITIES:
    • Leads the regulatory working team for own region and represents region as needed at project team and ensures regional regulatory lifecycle management strategy and submission planning written and executed according to plan - or oversees if delegated to staff and/or vendor
    • Partner with the regional/LOC RA and market access 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 are completed.
    • Where responsibility includes a marketed product, provides oversight to ensure regulatory compliance, including oversight of the product related data in the registration database.
    • Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within region 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 global and/ or regional regulatory strategies as well as executes day-to-day activities for projects.
    • May include some oversight of vendor activities.
    • Leads and manages meetings in own region (e.g. EMA for Europe) and have awareness of relevant regulatory agency meetings scheduled with other regions (such as FDA) or Local Takeda affiliates for project(s)/product(s) of responsibility.
    • May be called upon to support in due diligence for licensing opportunities, development and /or marketed product opportunities.
    • Builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to support Takeda strategic goals and objectives.
    • Identifies regulatory requirements across area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and /or Region in these areas.
    • Identifies and proposes solutions to the management of resource gaps for areas of responsibility.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
      • BS degree or equivalent in science; advanced degree preferred
      • Experience within the pharmaceutical industry, including direct experience in regulatory affairs in development and /or post-marketing phases.
      • Working knowledge of regulations and guidances governing drugs and biologics in development, including post-marketing in the US and/or EU (relevant to role). A good understanding of basic regulatory requirements in emerging markets is a plus. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
      • Understands and interprets complex scientific issues and capability to relate to regulatory requirements and strategy.
      • Proven regulatory submissions capability in a region (Europe, US, EM)
      • Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
      • Able to demonstrate skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
      • Generally strong in working well with others and within global teams.
      • Effective manager who is able to bring working teams together for common objectives.
      • Experience managing relationships with CROs and/or contractors preferred.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, Bethlehem , Senior Manager, EUCAN Regulatory Lead Neuroscience, Executive , Pen Argyl, Pennsylvania

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