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Regulatory Affairs Senior Associate/ Project Coordinator (JP7608)

Thousand Oaks, Ca · Biotech/Pharmaceutical
Job Title:  Regulatory Affairs Senior Associate/ Project Coordinator (JP7608)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Material Approval & Compliance
Duration: Initial 6 months with likely extensions
Posting Date: 8/24/2020
3Key Consulting Inc. is hiring a Regulatory Affairs Senior Associate for a contract engagement with our client, a leading global biopharmaceutical company.

Job Description:
  • 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 MSWord documents.
Top Must-Have Skill Sets:
  • 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 
Day to Day Responsibilities:
  • Perform Abbreviated reviews by manually comparing content or using Adobe Compare software to discern allowable differences were made from previous version of content for a label change via point of Important Safety Information (ISI) reference document.
  • Assist in authoring process documentation
  • Perform FDA communications archiving
  • Miscellaneous data hygiene projects to collect or update metadata in Veeva system of record
  • Product team support for process documentation authoring/updates in MS Word, Visio diagramming, Power Point slides creation and excel (vlookup and Pivot tables)
 Red Flags:
  • Less than intermediate Microsoft Office skills will be an issue - must be highly proficient in Microsoft office, including visio, powerpoint and sharepoint too if possible.
  • Should be able to take notes in a meeting setting and be able to work in a fast paced environment.
  • Must be good listener. High learning agility required. Must take directions well and have attention to detail
Interview process:
Phone followed by in-person interview
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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