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Regulatory Associate
Ref No.: 18-04116
Location: South San Francisco, California
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 management through the artwork process
  • Approve labeling changes
  • Closeout 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
  • Ability to work within tight timelines and prioritize workload
  • Fluent in Word, Powerpoint, Excel
  • Familiar with Adobe Acrobat
  • Familiar 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