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Associate Director, Global Regulatory Project Management and Strategic Planning - GI

Idaho State Job Bank
Boise, ID Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 5/4/2025

Associate Director, Global Regulatory Project Management and Strategic Planning - GI at Takeda Pharmaceuticals in Boise, Idaho, United States 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 three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - GI TAU within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products are established and maintained, and plans & directs the seamless execution of the GRT goals. Leads cross functional project submission working groups (SWG) to deliver successful submissions / filings and outcomes with Health Authorities (HA) for early to late phase programs by providing effective Project Management leadership, oversight, direction and planning. Directly supports program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless and delivering to expectations. Performs regulatory operational activities and directly oversees vendors providing operational support for assigned programs. How you will contribute : Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings , to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and submissions. Partner with the GRL to ensure Global Product Team (GPT) regulatory goals are cascaded and that the Global Regulatory Strategy Plan is operationalized and executed upon. Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units To view full details and how to apply, please login or create a Job Seeker account

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