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Senior Director, Global Regulatory Affairs - Oncology

Company: Takeda Pharmaceuticals International GmbH
Location: Boston
Posted on: April 11, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info. Senior Director, Global Regulatory Affairs - Oncology Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units. We are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us! Success What makes a successful member of our team? Check out the traits we're looking for and see if you have the right mix. Life at Takeda A Global Top Employer Recognized for our culture and way of working, we're one of only select companies to receive Top Global Employer -- status for 2021. Senior Director, Global Regulatory Affairs - Oncology Job ID R0032311 Date posted 03/08/2021 Location Boston, Massachusetts 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 Are 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 - Oncology in our Cambridge, Massachusetts office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director, Global Regulatory Affairs - Oncology 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 regulatory leadership 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 Senior 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 global and US FDA submissions and approvals of project(s) or oversees direct reports responsible.--
    • 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 required; BA accepted. Advanced degree such as Ph.D., PharmD or MS Degree preferred.--
      • 12+ years of pharmaceutical industry experience is required. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Global oncology regulatory experience preferred
      • 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 global 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 global 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 innovative 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. Job posting excludes CO applicants WHAT TAKEDA CAN OFFER YOU:
        • 401(k) with company match and Annual Retirement Contribution Plan
        • 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 Check out where you could be
          working if you apply. Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Boston , Senior Director, Global Regulatory Affairs - Oncology, Executive , Boston, Massachusetts

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