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Regulatory Operations Specialist - Pharma (Remote)
The Regulatory Operations Specialist will be a key contributor to the Aimmune Regulatory Operations team with accountability for submission operational activities and processes, vendor management, project management and negotiation skills; and knowledge of global regulatory dossier events and requirements to drive the execution of submissions. The Specialist must have Regulatory Operations/Publishing experience working in global markets, across various application types (IND, NDA, BLA, MAA, CTA), and demonstrated knowledge of eCTD XML structure and lifecycle management. Specific Responsibilities:• Oversee end-to-end dossier execution activities including submission planning and execution of all submissions throughout a product’s lifecycle (eg., early/late development,


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