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EUCAN Lead (Associate Director/Director), Regulatory Policy & Innovation

Company: Takeda Pharmaceutical
Location: Bethlehem
Posted on: September 20, 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 Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a EU Lead, Global Regulatory Policy & Innovation, where you will provide leadership for regulatory interactions on policy and advocacy issues. As part of the Global Regulatory Policy & Innovation Team, you will report to the EUCAN Head of Regulatory Policy & Innovation and contribute to Takeda's mission by building relationships with key regulatory decision makers at the European level. How you will contribute: Represent EUCAN Regulatory Policy & Innovation and GRA on EU-focused internal and external forums/networks as assigned. Provide impactful summaries and strategic advice, back to the business, regarding assigned activities. Provide leadership to influence the regulatory environment to meet our needs. Lead GRA and R&D participation in EU regional committees to lead networking and representation to guarantee a one voice policy. Work with GRPI to develop high quality and globally aligned regulatory policy strategies to facilitate product development. With GRPI colleagues, develop and execute a EU regulatory intelligence strategy. Remain current on internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may have impact to Takeda's regulatory and access strategies and propose action plan. Work and partner with GRPI colleagues and subject matter experts to plan and execute regulatory advocacy positions, strategies and tactics and facilitate engagement with regulators on main topics of interest. This includes to liaise with colleagues (R&D, Policy) leading policy activities in the external environment to ensure regulatory insights and overall agreement on Takeda position. Support and be accountable for the management of special projects such as US Regulatory Affairs Priority Topic list, position papers, and regulatory issues/trends reports, as assigned. Partner with Government/Public Affairs to understand and monitor evolving trends for Access requirements regionally, work with internal stakeholders to identify opportunities/threats and advocate Takeda's positions externally. Lead routine and ad hoc meetings within function and cross-functionally. Present to senior management as relevant. Demonstrate Takeda Leadership Behaviors. What you bring to Takeda: BS --- PhD, JD, MD, or equivalent. Track record working with a major regulatory agency, specific experience in government affairs or policy. 10 years of pharmaceutical industry experience. This is inclusive of 8 years regulatory experience or a combination of 10 years regulatory and/or related experience in both development and post-marketing phases. Knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the EU, with an understanding of basic regulatory requirements in other global markets (Japan, US) and emerging markets. Sound knowledge of intelligence tools and methods. Understand and interpret complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region. Excellent collaboration, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Experience at stakeholder engagement across organizational levels and boundaries. Must be strong communicator, and ability to explain complex regulatory issues, trends, and strategies to multiple stakeholders Must be strong leader that creates vision for group. Inspire and motivate group. Takes stand on important issues in productive, respectful way. Mentor and develop skills of staff. Experience managing relationships with CROs and/or contractors Locations Zurich, Switzerland Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Bethlehem , EUCAN Lead (Associate Director/Director), Regulatory Policy & Innovation, Executive , Bethlehem, Pennsylvania

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