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Global Regulatory Lead

Company: Takeda Pharmaceutical
Location: Lancaster
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 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
OBJECTIVES/PURPOSE
The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. There are two main drivers of innovation that are the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision Medicine.

The Global Regulatory Lead (GRL), Global Regulatory Affairs Strategy, Plasma-Derived Therapies Business Unit (GRA PDT BU):

  • Develops and directs global regulatory strategies, objectives and policies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the United States and international markets;
  • Serves as the global regulatory affairs lead for at least two or more plasma-derived therapy products and development assets;
  • Leads the Global Regulatory Team (GRT) composed of core regulatory support functions;
  • Serves as the primary liaison to the US FDA for assigned products and development assets and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities in Japan, the European Union and EEA region, Canada, and emerging markets. ACCOUNTABILITIES
    • Serves as the US and global regulatory strategy lead for assigned products and development assets
    • Owns and drives development and implementation of innovative regulatory strategies and risk mitigation approaches for assigned products and development assets in close close collaboration with relevant PDT BU R&D, Takeda R&D and Commercial functions to obtain, maintain and extend Takeda PDT BU product registrations in the United States, Japan, the European Union, EEA region, Canada, and emerging markets. This includes establishing and maintaining global regulatory strategy plans for assigned products and development assets in close collaboration with PDT BU CMC Regulatory Affair, EU Regulatory Strategy functions and the Takeda Payer Value and Patient Access function
    • Drives the tactical implementation of strategic regulatory plans for the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings and drives the creation of high quality, compliant regulatory documents (e.g., CTA, MAA, NDS, Variations, ODD, PIP and other relevant regulatory filings) within defined timelines as per Takeda PDT BU objectives
    • Leads Global Regulatory Teams for assigned programs and represents PDT BU regulatory affairs function on key internal program teams
    • S upervises, manages and coaches assigned team of US and International Regulatory Strategists
    • Proactively develops and fosters appropriate relationships with global regulatory agencies, especially the US Food and Drug Administration and international regulatory agencies to develop effective, professional relationships and advance a positive company image.
    • Serves as an active member of the PDT BU Regulatory Affairs team to help influence the operations and future strategy of the Takeda PDT BU R&D and Global Regulatory Affairs organization.
    • Owns and drives additional cross-cutting regulatory projects as assigned by the Head of Global Regulatory Strategy & US Regulatory Affairs DIMENSIONS AND ASPECTS
      Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
      • Extensive knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities
      • Demonstrated ability to develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities
      • Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve commercial goals
      • Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU, and international markets and versed in the overarching regulatory policy landscape in which biopharmaceutical companies operate
      • Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathwaysLeadership
        • Ability to motivate, mentor and manage a diverse team in a matrix environment
        • Global perspective with a demonstrated ability to work across functions, regions, and cultures
        • Ability to identify potential challenges and opportunities and make recommendations
        • Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
        • Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization
        • Invests in helping others learn and succeed
        • Able to influence without authority at senior (TET/TET-1) level
        • Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed. Decision-making and Autonomy ?
          • Accountable for acting decisively and exercise sound judgment in making decisions with limited information
          • Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence
          • Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities
          • Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution
          • Develops executable plans and meets budget and deadlines
          • Builds a culture of data driven decisions
          • Ability to challenge self and others to overcome regulatory barriers and deliver high quality solutions to the business
          • Ability to negotiate and influence without authority in a matrix environment
          • Crisp decision-making following appropriate consultation, even in times of ambiguityInteraction
            • Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU
            • Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions
            • Strong communicator, able to persuasively convey ideas verbally and in writing
            • Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholdersInnovation
              • Disruptive thinker with the ability to influence and change how PDT used data to make decisions and set priorities
              • Continuously challenging the status quo and bringing forward innovative solutions
              • Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.Complexity
                • Delivers solutions to abstract problems across functional areas of the business.
                • Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.
                • Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.
                • Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity
                • Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy
                • Resilient and comfortable working through large scale global change management EDUCATION AND EXPERIENCE REQUIREMENTS
                  • Minimum of 12 years of experience in drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities
                  • Minimum of 8 years in a Regulatory Affairs role of increasing responsibilities, with at least 3 years serving in a regulatory leadership position (e.g., GRL role)
                  • US and International regulatory affairs and global regulatory and/or health policy experience preferred
                  • Experience in plasma-derived therapies or biologics preferred
                  • Advanced scientific degree preferred (e.g., PhD, MD or JD)
                  • Extensive knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities
                  • Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals
                  • Crisp decision-making following appropriate consultation, even in times of ambiguity
                  • Demonstrated leadership skills and ability to inspire colleagues
                  • Ability to motivate, mentor and manage a diverse team in a matrix environment and to influence in a matrixed environmentWHAT TAKEDA CAN OFFER YOU:
                    • 401(k) with company match and Annual Retirement Contribution Plan
                    • Tuition reimbursement..... click apply for full job details

Keywords: Takeda Pharmaceutical, Rock Hill , Global Regulatory Lead, Other , Lancaster, South Carolina

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