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Team Lead, Global Reg Affairs, Device, PDT

Company: Takeda Pharmaceutical
Location: Groton
Posted on: November 24, 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 Shire Human Genetic Therapies, Inc., a Takeda company, is seeking a Team Lead, Global Reg Affairs, Device, PDT in Lexington, MA with the following requirements: Master's degree in Regulatory Affairs or related field or foreign academic equivalent plus 5 years of experience. Prior experience must include: Lead a team of engineers and specialists through device combination product projects creating compliant design history files towards regulator dossiers for agency submission (5 yrs); coordinate and guide a team of regulatory labelling specialists to produce instruction for use documents for the safe use of drug delivery devices (3 yrs); negotiate with global regulatory agencies and persuade the agencies to accept data packages towards drug device approval (5 yrs); monitor and assess regulatory guidelines and standards for the successful and compliant development of device drug combination product modalities (3 yrs). 15% 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 Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Newton , Team Lead, Global Reg Affairs, Device, PDT, Other , Groton, Massachusetts

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