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Regulatory Affairs Manager

1 month ago

Dubai, Dubai, United Arab Emirates ClickJobs Full time

JobDescription

Takeda DevelopmentCenter Americas, Inc. is seeking a Manager, Global RegulatoryAffairs CMC in Cambridge, MA with the following requirements:Master's degree in Regulatory Affairs or related fieldplus 2 years of related experience. Prior experience must include:Develop the regulatory submission strategies for products incommercial and development phase by working in close coordinationwith the quality, manufacturing and global regulatory teams; Ensurethe response to health authority queries are provided in a timelyand efficient manner by working with regulatory teams acrossdifferent regions; Submit the compliance submissions such as annualreports (BLA), yearly biologic periodic reports and licenserenewals in a timely manner to ensure the marketed products are incompliance with Health Authority requirements; Provide regulatoryassessments for change controls for various markets such as US FDA,EMA, Health Canada as well as liase with in-country regulatoryrepresentative to provide the assessments. Up to 20% remote workallowed.

Apply on-line at and search for Req#R0119855.

Takeda CompensationAnd Benefits Summary

Weunderstand compensation is an important factor as you consider thenext step in your career. We are committed to equitable pay for allemployees, and we strive to be more transparent with our paypractices.

ForLocation:

Boston,MA

U.S. Base SalaryRange:

$133,000.00 -$209,000.00

The estimated salary rangereflects an anticipated range for this position. The actual basesalary offered may depend on a variety of factors, including thequalifications of the individual applicant for the position, yearsof relevant experience, specific and unique skills, level ofeducation attained , certifications or other professional licensesheld, and the location in which the applicant lives and/or fromwhich they will be performing the job. The actual base salaryoffered will be in accordance with state or local minimum wagerequirements for the job location.

Key Skills
InterpersonalCommunication,Legal
Employment Type: Full Time
Department / FunctionalArea: Lawyers,Legal Advisors
Experience: 0 Years - 1 Years years
Vacancy: 1
Joining Date: Fri, 31 Jan 2025