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Regulatory Affairs Senior Associate-Pharm/biotech experience

  • Anywhere

Company :
Infotree Service Inc

Location :
El Conejo, California

Expiry Date :
Thu, 08 Apr 2021 23:59:59 GMT

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Description :
Job Description

Remote until COVID restrictions are lifted for local candidates, fULLY REMOTE FOR NON LOCAL CANDIDATES

Pharm/biotech experience required

Administrative projects as backup support of Operations staff during project period. Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (Veeva RIM) archiving and other process documentation authoring support). Create and maintain product regulatory documents and appropriately archive all regulatory documents and agency communications per process. Coordinate QC of regulatory documentation for FDA submission (e.g. Request for Advisory Comments and other FDA communications). Generate Digital Asset Management (DAM) reports for vendor management program. Manage and host formal WebEx meetings with meeting minutes. Creation of Infographics, slides, technical editing of process documents, and proofreading. Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents. Experience in labeling and Regulatory document management. Experience in promotional review and approval process. Experience in Tableau. Remote position with flexible work hours to accommodate EST employees project needs.