Job Description
Our client is looking for a Sr. Regulatory Affairs Lead with 10+ years of experience preferably from an Oncology background with a dual focus in Pharmaceuticals and Medical Devices. The Client is currently developing one of their vendors (USR) so some regulatory oversight will be required and would need someone to submit a fast track designation for one of their products. One of their protocols will require a discussion with the FDA so prior FDA facing experience would be beneficial, as this regulatory professional would need to discuss with the FDA so they will accept what would be done. This FDA meeting will need to be set up to discuss the development of imaging device. Other regulatory submission (IND,NDA,BLA,MAA) experience would be great have for future potential needs.
Required Skills
Regulatory Affairs
Imaging Device Experience
Device Development
Regulatory Submissions (IND/NDA/BLA/MAA)
FDA Meetings / FDA Facing
Fast Track Designation
Oncology
BS/BA
MS/MA
Remote: Sr. Regulatory Affairs Lead (232438)
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