Regulatory Associate I

South San Francisco, CA 94080

Posted: 08/20/2018 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 4669

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties:
  • Responsible for product labeling, including the carton, label and insert labeling components.
  • Initiate labeling changes via the artwork process
  • Review and proofread the labeling changes
  • Track labeling changes and project manage through the artwork process
  • Approve labeling changes
  • Close out labeling files, ie electronic file closeout
  • Process and submit labeling portion of the Biologics License Application (BLA) and New Drug Applications (NDA) yearly Annual Reports.
  • Utilize database and RAPID system to compile data.
  • Partner with Regulatory Submissions group to submit labeling portion of Annual Reports
  • Special projects as assigned.

 

 

Skills:

  • Exceptional proofreading skills and attention to detail
  • Effective time management
  • Able to work independently
  • Ability to learn and adapt to new systems and processes
  • Abililty to work within tight timelines and prioritize workload
  • Fluent in Word, Powerpoint, Excel
  • Familiar with Adobe Acrobat
  • Familar with Touchpoint, RAPID, Trackwise

 

Education:

  • 5 years Pharm/Biotech experience
  • Regulatory experience desired
  • Bachelors Degree required (Life Sciences disciplines strongly preferred)
  • Quality experience is a plus
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