Associate Director, Global Regulatory Affairs

Takeda 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 https://jobs.takeda.com and search for Req # R0136180.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time

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