Associate Director, Global Regulatory Affairs

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, and 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 work 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 online at

https://jobs.takeda.com

and search for Req # R0136180.Locations

Boston, MAWorker Type

EmployeeWorker Sub-Type

RegularTime Type

Full time

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