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Regulatory Affairs Specialist (Pipeline)
Ref No.: 18-00079
Location: Piscataway, New Jersey
Start Date / End Date: 01/01/2018 to 12/31/2018
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,

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

BS in Biology/Chemistry or related field