Manager Global Regulatory Affairs CMC

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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 www.takedajobs.com and search for Req # R0055772

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Boston, MA

Employee

Regular

Full time