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Title : SG- Regulatory Affairs Specialist III -267
State : Pennsylvania   Date : Mar 30, 2020
Experience Level :  
Position Type : Regulatory Affairs Specialist III      
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 III

Duration: 5+ months (extendable) contract on W2

Duties:

Candidate to author/review/approve CMC technical documents in the Client’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

Skills: 

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

Education: BS in Biology/Chemistry or related field.



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
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