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Senior Director, Global Regulatory Affairs - GI

Company: Takeda Pharmaceutical
Location: Quincy
Posted on: November 19, 2021

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 company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.- Join us as a Senior Director, Global Regulatory Affairs - GI in our Cambridge office.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director, Global Regulatory Affairs - GI working on the Global Regulatory Affairs team, you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects, and a typical day will include:-Objectives:

  • 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 within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable.
  • Provides leadership and development for direct reports, 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 Sr. Director will be responsible for overseeing an assigned portfolio of projects or highly complex projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT 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. Demonstrates ability to anticipate 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 or oversees direct reports responsible.- The Sr. Director will lead all submission types.
    • Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings. Oversees direct reports 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 task-forces and initiatives.- Influence non-direct reports within Therapeutic Area, across GRA and across R&D.
    • 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 behaviors.Requirements:
      • BSc Degree, preferred.- BA accepted.
      • 12+ years of pharmaceutical industry experience.- This is inclusive of 10 years of regulatory experience or combination of 8+ 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.WHAT TAKEDA CAN OFFER YOU:
        • 401(k) with company match and Annual Retirement Contribution Plan
        • Tuition reimbursement
        • Company match of charitable contributions
        • Health & Wellness programs including onsite flu shots and health screenings
        • Generous time off for vacation and the option to purchase additional vacation days
        • Community Outreach Programs
        • Empowering Our People to ShineLearn more at .No Phone Calls or Recruiters Please.#LI-LC1Effective November 1, 2021, absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles.- US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.EEO 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

Keywords: Takeda Pharmaceutical, Quincy , Senior Director, Global Regulatory Affairs - GI, Executive , Quincy, Massachusetts

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