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Title : SA- Regulatory Affairs Specialist II - CMC -969
State : Pennsylvania   Date : Nov 20, 2018
Experience Level :  
Position Type : SA- Regulatory Affairs Specialist II - CMC      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Swiftwater, PA


Job Title: Regulatory Affairs Specialist II - CMC


Duration:  6+ months (extendable) contract on W2


Duties:

Suppliers- the CMC position is not on the published rate card.  Please submit up to a max bill rate of (USD)73.85

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  



Skills:


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)
 

Education:


BS / BA in Biology / Chemistry or related field




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Many Thanks,   

Sree Kanth
Associate Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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Princeton , NJ 08540 
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