Global Regulatory Labeling Strategy Manager
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: May 13, 2022
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Job Description:
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application process with Takeda will commence and that the
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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 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 www.takedajobs.com 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, Jersey City , Global Regulatory Labeling Strategy Manager, Executive , Jersey City, New Jersey
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