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Regulatory Affairs - CMC

Allentown-Bethlehem-Easton Metro Area, Pennsylvania

Post Date: 05/08/2017 Job ID: JN -052017-19007
  • BS in Biology/Chemistry or related field with 3+ years experience in Regulatory Affairs including CMC
    Regulatory Affairs Specialist supporting 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
  • Candidate to author technical documents into 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.
  • Experience 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,
  • 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

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