Global Regulatory Labeling Strategy Manager
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 9, 2022
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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 Global Regulatory Labeling Strategy Manager in
Cambridge, MA with the following requirements: Bachelor's degree in
Chemistry, Pharmacy or closely related field plus 3 years related
experience. Prior experience must include: provide labeling
strategy by assessing global/local labeling regulations, competitor
labeling, labeling trends, collating historical Health Authority
feedback, and company internal data to optimize the product
labeling for the benefit of the patient while ensuring regulatory
compliance; collaborate with the cross-functional teams to
author/review/update company core data sheet (CCDS), regional/local
labeling (USPI and EU SmPC) and supporting documentation for
regulatory submissions; prepare response documents and backup
strategies for label negotiations with Health Authorities to
address the labeling-related queries by interpreting clinical and
scientific data from Clinical study reports, Safety summaries,
toxicology reports, chemistry/manufacturing reports and other
sources; evaluate risks associated with CCDS content and
implementation strategies, develop mitigation plans, and
appropriately escalate issues to Global Labeling management and the
Global Regulatory Lead. Up to 5% travel required.Apply on-line at
and search for Req # R0063612.EEO StatementTakeda is proud in its
commitment to creating a diverse workforce and providing equal
employment opportunities to all employees and applicants for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, gender expression, parental status,
national origin, age, disability, citizenship status, genetic
information or characteristics, marital status, status as a Vietnam
era veteran, special disabled veteran, or other protected veteran
in accordance with applicable federal, state and local laws, and
any other characteristic protected by law.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cherry Hill , Global Regulatory Labeling Strategy Manager, Executive , Cherry Hill, New Jersey
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