Global Regulatory Labeling Strategy Manager

Company: Takeda Pharmaceutical
Location: New Brunswick
Posted on: May 12, 2022

Job Description:

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Job Description
Takeda 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 Statement
Takeda 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.

Locations
Boston, MA

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Keywords: Takeda Pharmaceutical, New Brunswick , Global Regulatory Labeling Strategy Manager, Executive , New Brunswick, New Jersey