Associate Director, Global Regulatory Affairs
Company: Takeda Pharmaceutical
Location: Boston
Posted on: October 30, 2024
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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 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
Keywords: Takeda Pharmaceutical, Lowell , Associate Director, Global Regulatory Affairs, Executive , Boston, Massachusetts
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