15 Manager, Global Regulatory Affairs CMC Jobs in Boston, MA
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Manager, Global Regulatory Affairs CMC
$142k-189k (estimate)
Full Time | Scientific Services
1 Week Ago
Biospace is Hiring a Manager, Global Regulatory Affairs CMC Near Boston, MA
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’sPrivacy Noticeand Terms of Use. 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 https://jobs.takeda.com and search for Req #R0123032.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
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 https://jobs.takeda.com and search for Req #R0123032.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job Summary
JOB TYPE
Full Time
INDUSTRY
Scientific Services
SALARY
$142k-189k (estimate)
POST DATE
06/20/2024
EXPIRATION DATE
07/18/2024
WEBSITE
biospace.com
HEADQUARTERS
CERRITOS, CA
SIZE
50 - 100
FOUNDED
1985
CEO
KI CHUL CHA
REVENUE
$10M - $50M
INDUSTRY
Scientific Services
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About Biospace
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