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Scientific. Clinical. Software Engineering

Regulatory Affairs Specialist

Allentown-Bethlehem-Easton Area, PA

Job Type: Scientific Job Number: JN -102019-25780 Region: Allentown-Bethlehem-Easton Area

Job Description


Candidate to author/review/approve CMC technical documents in company s internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities. Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC. Provide regulatory guidance for development projets, post-approval CMC changes/variations. 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 with drug/biologics licensure

Prior regulatory experience

Technical writing experience (CMC experience)

Scientific background


CMC/ Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3

Scientific background, vaccines preferred

Microsoft Office (word, excel, powerpoint)

Documentum/ Veeva Applications

Trackwise Applications

ICH Guidelines

GMP experience

Experience with drug/biologics licensure preferred

Prior regulatory experience


BS in Biology/Chemistry or related field

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