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Regulatory Affairs Specialist II - CMC
Ref No.: 18-14442
Location: Swiftwater, Pennsylvania
Title - Regulatory Affairs Specialist II - CMC
Location - Swiftwater PA
Duration - 06+ Months 

Candidate to author CMC (Module 2.3 and 3) Common Technical Documents (CTDs) supporting an international, initial product registration at a minimum. The candidate must have working knowledge of biologics (preferably viral vaccines) and regulations pertaining to pre and post licensure CMC activities. Working knowledge must also include an understanding of ICH/ GMPs guidelines with EU regulatory experience regarded as a plus. The candidate must be well-organized, work with minimal management and meet aggressive timelines. Must utilize knowledge of word processing (software capabilities / functionality) and exhibit strong writing / analytical skills.
Experience: 3 to 6 years with regulatory experience in drug/biologics licensure (EU regulatory experience preferred) including CMC technical writing

CMC / Regulatory writing experience - minimum of 3 years authoring CMC documentation (CTDs)
Scientific background (vaccines preferred)
Microsoft Office (Word, Excel, Powerpoint, Visio, Outlook)
Electronic documentation file systems (Veeva Vault)
ICH / GMP guidelines
Experience with drug/biologics licensure (EU preferred)