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Director, Global Regulatory Lead

Company: Takeda
Location: Cambridge
Posted on: November 20, 2023

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 Description

About the role:

Plasma-derived therapies are critical, life-saving medicines, which patients with rare and complex diseases around the world rely on every day. Global demand for these therapies, particularly immunoglobulins, has increased dramatically over the last 15 years, and continues to grow. Takeda is established as second largest provider of plasma-derived therapies (PDT) globally. Leveraging on 75+ year pioneering legacy, Takeda believes there is tremendous potential to do more to meet expectations of patients and health care providers with plasma-derived therapies for patients with immunologic, hematologic, autoimmune and other complex diseases.

Reporting to the Therapeutic Area Global Regulatory Strategy Lead for PDT in our Cambridge, MA office, you will be the global regulatory lead for one or more projects and this will include leadership of the Global Regulatory Team (GRT) composed of core regulatory support functions.

How you will contribute:

  • Creation of global regulatory strategies for assigned programs and ensures the global regulatory strategies for assigned programs are up-to-date
  • Collaborate with EU, Japan, China and other regional counterparts in compiling global regulatory strategies and work with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and execution of the strategy is met
  • Lead the global regulatory subteam (GRT) and represent the GRT at GPT, subteams and working groups
  • Create high quality, complaint regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines
  • Accountable for all US FDA submissions and approvals for assigned programs
  • Lead FDA health authority interactions/meetings related to assigned programs and support regional and local regulatory affairs teams with health authority interactions
  • Ensure GRT, GPT, line management, and key stakeholders are informed of developments that may affect regulatory success
  • Ensure accurate, up-to-date reporting of program status and milestones globally through the InterACT system and regulatory dashboard and uses the Dragonfly visualization tool to highlight any major discrepancies for assigned programs


    Minimum Requirements/Qualifications:
    • BSc degree, BA degree accepted
    • Minimum of 10 years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience with at least 5 years in regulatory strategy or a combination of regulatory strategy and equivalent experience
    • Knowledge of global regulatory requirements and prior FDA interactions/submissions experience
    • Previous experience developing flexible approaches to achieve commercial goals


      What Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • 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 and company match of charitable contributions
      • Family Planning Support
      • Flexible Ways of Working
      • Tuition reimbursement


        More about us:

        At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

        Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

        This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

        In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

        EEO Statement

        Takeda 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.

        Locations

        Cambridge, MA

        AUT - Wien - DC Tower

        Worker Type

        Employee

        Worker Sub-Type

        Regular

        Time Type

        Full time

Keywords: Takeda, Cambridge , Director, Global Regulatory Lead, Executive , Cambridge, Massachusetts

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