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Regulatory Affairs Specialist

Allentown-Bethlehem-Easton Metro Area, Pennsylvania

Post Date: 05/08/2017 Job ID: JN -052017-19008 Industry: Regulatory - Scientific
Description:

Duties
:
  • Candidate to author technical documents in Sanofi s internal documentum system.
  • Must have working knowledge of bacterial biologics and regulations pertaining to pre and post licensure activities related to CMC.
  • Must have working knowledge of GMPs.
  • Must be well-organized, work with minimal management and meet aggressive timelines.
  • Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.
  • **This position is working in the CMC area.
  • Relevant experience is required
  • Experience: 3 to 6 years
  • Experience with drug/biologics licensure
  • Prior regulatory experience
  • Technical writing experience (CMC experience )
  • Scientific background,
Skills:
  • CMC/ Regulatory writing experience
  • Scientific background, vaccines preferred
  • Microsoft Office (word, excel, powerpoint)
  • Documentum Applications
  • Trackwise Applications
  • ICH Guidelines
  • GMP experience
  • Experience with drug/biologics licensure
  • Prior regulatory experience
Education:
  • BS in Biology/Chemistry or related field

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