Manager, Global Regulatory Affairs CMC Submissions Management

Bio-Life Plasma, LLC

Lexington, MA

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Job Description

Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: Bachelor’s degree in a scientific field or foreign academic equivalent plus 4 years of related experience. Required skills: Ability to work with firm deadlines and adapt quickly to changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently; experience with global CMC regulations for advanced therapies and biological compounds; knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development. Up to 20% domestic travel required. Up to 50% remote work allowed.

Full time. $138,500 - $186,000 per year.

Apply on-line at and search for Req #R0122887.

Lexington, MA
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