Manager Global Regulatory Affairs CMC

Company: Takeda Pharmaceutical
Location: Malden
Posted on: November 24, 2022

Job Description:

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Job Description

Takeda Development Center Americas, Inc. is seeking a Manager Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Bachelor's degree in pharmacy, pharmaceutical sciences or related field plus 5 years related experience. Prior experience must include: ensures compilation, review, and submission of the drug product dossiers, following regulatory guidelines and internal processes within timelines, and respond to various queries to achieve timely approvals; post-approval changes evaluation using Trackwise, strategizing, and perform its impact analysis across all licenses to file variations; coordinates with vendors for project support activities and communicates with cross-functional colleagues to share/keep track of updations on the projects; organizes and maintains submission components associated with a regulatory submission electronically, including electronic processing of documents and uploading in e-CTDXpress. 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, Malden , Manager Global Regulatory Affairs CMC, Executive , Malden, Massachusetts