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Regulatory Affairs Specialist

Allentown-Bethlehem-Easton Metro Area, Pennsylvania

Post Date: 07/18/2017 Job ID: JN -072017-19553
Description:
Candidate to author technical documents in 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 ) - 3 + years of experience authoring CMC regulatory documents
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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