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Associate Director, Global Regulatory Affairs Marketed Products Group

Company: Takeda Pharmaceutical
Location: Saugus
Posted on: September 25, 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 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 Description Takeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs Marketed Products Group in Cambridge, MA with the following requirements: Bachelor's degree in scientific field plus 8 years related experience. Prior experience must include: interpret complex scientific issues across multiple product portfolios and therapeutic areas of responsibility (including general medicine, gastroenterology, oncology, plasma derived therapies) as it relates to regulatory requirements and strategy; formulate innovative regulatory strategies to achieve competitive and accelerated product approvals based on the regulations/guidance knowledge acquired in oncology drug development; identify potential risks (supply chain, manufacturing, safety/pharmacovigilance, quality, etc.) to the regulatory strategy and proactively develop mitigations; author and review documents required for Marketing Authorization Application (MAA) submissions to Health Authorities in the Growth & Emerging Markets region. Up to 30% travel required.Apply on-line at and search for Req # R. 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, Boston , Associate Director, Global Regulatory Affairs Marketed Products Group, Executive , Saugus, Massachusetts

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