Global Regulatory Labeling Strategy Manager

Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 9, 2022

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

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