Manager, Regulatory Informatics and Analytics

Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: November 14, 2023

Job Description:

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Job Description

Takeda Development Center Americas, Inc. is seeking a Manager, Regulatory Informatics and Analytics in Cambridge, MA with the following requirements: Bachelor's degree in Pharmaceutical Sciences or related field or foreign equivalent plus 4 years related experience. Required skills: Define, implement and roll out of regulatory operation publishing standards and mechanism utilizing International Conference Harmonization requirements, FDA Electronic submission gateway web trader requirements, EU, US and GCC eSubmission requirements, and effective cross Research and Development functional collaborations; present and submit compliance global dossiers to global health authorities by applying lifecycle management and electronic common technical document philosophies as well as adopting the use of eCTDXpress, XML viewer tools and health authority recommended validation tools; lead workstreams which aid in streamlining and optimizing regulatory operation processes including routine discussions with workstream members on expectations and RACI matrix, prepare and deliver presentations to regulatory operations and the wider Research and Development divisions; initiate implementation of regulatory submission software's and tools through authoring User Requirements Specifications, collaborate with industry leading publishing vendors and organize demos for the regulatory organization.

Apply on-line at www.takedajobs.com and search for Req #R0110445.

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, MAWorker Type

EmployeeWorker Sub-Type

RegularTime Type

Full time

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