CherryHillRecruiter Since 2001
the smart solution for Cherry Hill jobs

Manager, Global Regulatory Affairs CMC

Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: June 4, 2024

Job Description:

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionTakeda 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 and search for Req #R0123032.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Cherry Hill , Manager, Global Regulatory Affairs CMC, Executive , Cherry Hill, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Cherry Hill RSS job feeds