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Senior Manager, Global Regulatory Affairs Development GI

Company: Takeda Pharmaceutical
Location: Mount Vernon
Posted on: November 21, 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 and . 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, Global Regulatory Affairs Development GI in Zurich, Switzerland. Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVE:

  • Leads global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives.
  • Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -ACCOUNTABILITIES:
    • The Senior Manager role may include managing multiple projects or projects with greater complexity. Leads the Global Regulatory Team (GRT and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Provides strategic and tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
    • Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
    • Responsible for developing solutions to identified risks and discussing with team and management.
    • Accountable for all US FDA submissions and approvals for project(s) within scope and can independently negotiate issues. The Senior Manager role may lead more complex submission types such as supplements or support other GRLs for highly complex submissions.
    • Contribute significantly to the preparation for Agency meetings; may lead FDA meeting with management oversight.
    • Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
    • Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
    • Participate in departmental or cross-functional task-forces and initiatives.
    • May participate on due diligence projects with oversight.
    • Partner with functions responsible for ensuring market access and regional GRA leads to understand market access topics and strategize opportunities to strengthen product development plan(s) and build into global integrated regulatory strategy.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
      • BSc Degree preferred. BA accepted.
      • 6+ years of pharmaceutical Industry experience. This is inclusive of 5 years of regulatory experience or combination of 6+ years regulatory and/or related experience.
      • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
      • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
      • Understand and interpret complex scientific issues across multiple projects as -it related to regulatory requirements and strategy.
      • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
      • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
      • Demonstrates acceptable skills with increasing independence 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.
      • Must work well with others and within global teams.
      • Able to bring working teams together for common objectives.
      • Acceptable and independent 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.PHYSICAL DEMANDS:
        • Manual dexterity required to operate office equipment (i.e., computers, phones, etc.).
        • Carrying, handling and reaching for objects. -
        • Ability to sit or stand for long periods of time while traveling.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 At our heart we 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, sexual orientation, race, colour, ethnic or social 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, Mount Vernon , Senior Manager, Global Regulatory Affairs Development GI, Executive , Mount Vernon, New York

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