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Senior Regulatory Affairs Specialist; CMC/Biologics
Job in
Swiftwater, Monroe County, Pennsylvania, 18370, USA
Listed on 2026-02-28
Listing for:
Artech Information System LLC
Full Time
position Listed on 2026-02-28
Job specializations:
-
Healthcare
Healthcare Compliance
Job Description & How to Apply Below
An IT staffing company in the US is seeking a Regulatory Affairs Specialist V to author technical documents within the internal documentum system.
The right candidate should have a strong scientific background, particularly in bacterial biologics, and knowledge of GMP standards relevant to clinical materials. Additionally, 3–6 years of regulatory experience in drug/biologics licensure is essential. Candidates should possess excellent writing and analytical skills and should be able to work independently under aggressive timelines.
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Position Requirements
10+ Years
work experience
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