Takeda
Pharma
Director,GlobalRegulatoryLead-Oncology
Neural analysis suggests this role is
optimal for Director candidates.
“Director, Global Regulatory Lead - Oncology at Takeda. Skills: Regulatory affairs, Oncology, Compliance. Develop regulatory strategies. Manage regulatory submissions”
Industry & Context.
Regulatory problem solving
What You'll Do.
Develop regulatory strategies
Manage regulatory submissions
Ensure compliance with regulations
Provide regulatory guidance
Oversee regulatory lifecycle management
Analyze regulatory risks
Collaborate with cross-functional teams
Interpret regulatory requirements
How You'll Work.
Team & Collaboration
Cross-functional teams
Communication Scope
Regulatory communication
Full 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](https://jobs.takeda.com/privacynotice) and [Terms of Use](https://www.takeda.com/terms-and-conditions/). 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. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Director, Global Regulatory Lead Oncology you will set global regulatory strategy and lead major submissions for high-impact oncology programs. # **How you will contribute:** * Oversee as well as execute all regulatory activities of one or multiple complex projects in development and/or supports regulatory activities for assigned projects. * Serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility. * May lead the global regulatory sub-team (GRT) for assigned projects. * May serve as global and/or regional regulatory lead as a member of a GRT * Primary FDA contact for projects of responsibility. *
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