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.

Senior Associate – Specialist, Global Regulatory Affairs CMC role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:  

• With supervision, support the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products.  

• Support RA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.  

• With supervision, prepare  project plans and timelines for CMC submission activities and responsible for organization of CMC-related documents for regulatory submissions. 

• Expected to have a sound understanding of global RA CMC regulations and guidelines and participate in the development of strategies to enhance probability of regulatory success or enhancing regulatory compliance. Has ability to apply this understanding to support the development and execution of strategies to enhance probability of regulatory success and regulatory compliance. 

• Sound analytical or process understanding that enables the development of robust and accurate submissions. 

• Assist in the coordination of communication and collaboration among internal and external colleagues. 

Minimum Requirements/Qualifications:

• PhD / PharmD, or MS/BS with 3+ years of relevant pharmac