Senior Regulatory Affairs Associate

Title: Senior Regulatory Affairs Associate 
Pay: Up to $38.00/hr  
Location: Thousand Oaks, CA 91320
Length: 5 month contract + possible extension

Job Details:

• Assist US Promotion Regulatory Representatives to support US Promotion regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) and other process documentation authoring support, Veeva data entry and collection)
• Create and maintain product regulatory history documents through IMR/Veeva and appropriately archive all regulatory documents and agency communications per process.
• Coordinate QC of regulatory documentation (e.g. Request for Advisory Comments and other FDA communications)
• Administrative projects in support of Material Compliance Managers and Operations staff during project period. Create PowerPoint, Visio, manipulate data in Excel spreadsheets and author/update MS Word documents.

Top Must Have Skill Set:

• Process document technical authoring capabilities
• FDA submission experience
• Insight Manager Registrations (IMR) and/or Veeva experience
• Ability to compare content manually or using Adobe Compare software
• Intermediate to advanced Microsoft Office, including Visio, Excel, and SharePoint skills