Associate Director, Global Regulatory Affairs

Company: Takeda Pharmaceutical
Location: Boston
Posted on: November 12, 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 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 DescriptionTakeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs in Cambridge, MA with the following requirements: Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field plus 7 years of related experience. Prior experience must include: In the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead (GRL), on the global project team (GPT) for accountable individual projects; Provide global regulatory oversight and execute regulatory activities on late-stage development in multiple indications, device platforms, cell line changes; Global experience of health authority interactions including preparation meetings with FDA, US (type B, end of phase 2 meeting), EMA, (EU) central scientific advice, BRDD, (Canada) Scientific Advice and PMDA, (Japan) Scientific Advice; Lead the development of high level global regulatory supplemental biologic application sBLA strategy and the KO of global cross functional submission working group. Lead global submission strategy across multiple respiratory indications and worked with global regulatory team to ensure multiple global pre-submission meetings and marketing application submissions. Up to 20% domestic and international travel required.Full time. $212,400.00 - $290,400.00 /year.Apply on-line at and search for Req # R0136180.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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