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Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of Baxter’s products. Track of status and progress of regulatory documentation. Review, edit and proofread regulatory documentation. Assist in preparation and review of labeling, SOP’s, and other departmental documents. Compile under supervision regulatory documents for submission. Participate as an active team member of project teams as required,. Compile and prepare responses to regulatory authorities questions . Maintain regulatory files in a format consistent with requirements. Maintain awareness of regulatory requirements. May be responsible for a specific product portfolio in the region
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Poster Supplement
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
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