Manager, Global Regulatory Affairs CMC Submissions Management

Company: Takeda Pharmaceutical
Location: Lexington
Posted on: October 23, 2024

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionTakeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: Bachelor's degree in a scientific field or foreign academic equivalent plus 4 years of related experience. Required skills: Ability to work with firm deadlines and adapt quickly to changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently; experience with global CMC regulations for advanced therapies and biological compounds; knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development. Up to 20% domestic travel required. Up to 50% remote work allowed.Full time. $178,500 - $202,000 per year.Apply on-line at and search for Req #R0133816.LocationsLexington, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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