Requires a Bachelor degree in chemistry or a related field and 4 years of experience in the job offered or 4 years of Regulatory Operations experience with a focus on eCTD submission publishing, formatting, and archiving. Also required is 4 years of experience publishing IND, NDA and BLA submissions for US, EMA, and RoW countries; using regulatory IT tools such as Global Submit, Sharepoint, document management systems, ISI Toolbox, Insight for publishing, and Liquent Insight viewer; archiving submitted documents; and supporting postapproval life cycle management. Must also possess 2 years of experience testing and implementing Regulatory Information Management RIM systems. Reports to Ultragenyx Pharmaceutical, Inc. office in Brisbane, CA but may telecommute from any location in the United States.

Categories: eb3

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