Associate Director, Global Regulatory Affairs Development - GI

Company: Takeda Pharmaceutical
Location: York Haven
Posted on: May 16, 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 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 Associate Director, Global Regulatory Affairs Development - GI in our Cambridge MA office.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, GRA Development - GI working on the Global Regulatory Affairs team, you will be empowered to be strategic and innovative, and a typical day will include:POSITION 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.POSITION ACCOUNTABILITIES:
  • The Associate Director will be responsible for increasingly complex or multiple 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.
  • 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 or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs.
  • Direct point of contact with FDA, 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 departmental and cross-functional task-forces 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, EXPERIENCE AND SKILLS:
    • BSc Degree, preferred. BA accepted.
    • 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ 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.
    • 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.TRAVEL REQUIREMENTS:
      • Willingness to travel to various meetings, including overnight trips.
      • Requires approximately up to 10-30% travelLocation and Salary Information:
        • This job posting excludes CO applicants.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 ProgramsEmpowering Our People to Shine
            Learn more at takedajobs.com.No Phone Calls or Recruiters Please.
            • LI-LC1Absent 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. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. 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. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you 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

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