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Associate Director, Global Regulatory Affairs Development GI

Company: Takeda Pharmaceutical
Location: West Orange
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 -an Associate Director, Global Regulatory Affairs Development GI to be based in Zurich, Switzerland. Here, you will be a vital contributor to our inspiring, bold mission.OBJECTIVE:

  • Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
  • Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
  • Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.
  • Provides leadership and development for direct reports if applicable, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -ACCOUNTABILITIES:
    • The AD will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides 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.
    • Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
    • Accountable for all US FDA submissions and approvals of project(s) of responsibility. The AD will lead all submission types.
    • Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
    • 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.
    • Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
    • Lead regulatory reviewer in due diligence for licensing opportunities.
    • Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
    • Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
    • Responsible for demonstrating Takeda leadership behaviorsEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
      • BSc/BA Degree, scientific discipline strongly preferred.
      • Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred.
      • 8+ years of relevant scientific/pharmaceutical industry 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, UK, Japan, China, Canada and 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.
      • 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% 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, West Orange , Associate Director, Global Regulatory Affairs Development GI, Executive , West Orange, New Jersey

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