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Manager, Global Regulatory Affairs CMC
4 months ago
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 Takedas 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: Masters 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.
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