Manager, Global Regulatory Affairs CMC
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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 : Master’s degree in Regulatory Affairs or related field plus 2 years of related experience.
- Prior experience must include : Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams;
- Ensure the response to health authority queries are provided in a timely and efficient manner by working with regulatory teams across different regions;
- Submit the compliance submissions such as annual reports (BLA), yearly biologic periodic reports and license renewals in a timely manner to ensure the marketed products are in compliance with Health Authority requirements;
Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments.
Up to 20% remote work allowed.
Full time. $133,200.00 to $223,200.00 / year.
Apply on-line at https : / / jobs.takeda.com and search for Req #R0123032.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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