In this role, you will oordinate the review and assemble regulatory submissions (NDAs, INDs), amendments and post-approval supplements including review and evaluation of supporting documentation for accuracy and conformance with the applicable ICH and FDA regulations and guidances.
In this role, the successful candidate will plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines under the guidance of more senior regulatory professionals.
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$45K to $75K -Tarrytown, NY
This position prepares regulatory submissions for in vitro diagnostic products for international registrations. Focus will be on new product registration and re-registration of products in China. Must possess good technical writing skills and have a scientific background.