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Manager, Global Regulatory Affairs CMC Submissions Management

Employer
Takeda Pharmaceutical (US)
Location
Lexington, Massachusetts, United States
Salary
Competitive
Start date
1 Oct 2024
Closing date
4 Oct 2024
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Discipline
Regulatory Affairs, CMC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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

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. $178,500 - $202,000 per year.

Apply on-line at https://jobs.takeda.com and search for Req #R0133816.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Company

At Takeda, our strong, focused team of globally diverse colleagues are united by a shared vision, values and mission: to bring better health and a brighter future to people worldwide. To enable this, we foster a working environment where employees are empowered to respond in the way that best meets the needs of our patients. Working with us, you will make a positive impact on people’s lives every day — including your own.

Company info
Website

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