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Employment Type:
Full time
Job Category:
Health Care Provider
Regulatory Affairs Specialist
AustarPharma LLC | Newark, New Jersey
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Job Description

Regulatory Affairs Specialist

AustarPharma LLC in Edison, NJ is seeking a Regulatory Affairs Specialist: MS in Pharmaceutics, Pharmaceutical Chemistry or closely related fields with at least 1 year of experience in collecting and reviewing technical CMC documents, reviewing clinical study protocols and reports, and providing guidance to ANDA R&D departments for FDA and cGMP compliance. Experience in drug development with solid dosage form, drug analysis, drug delivery and clinical trial design is also required. 

Web Id: 95074


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About AustarPharma LLC

AustarPharma is committed to long-term relationship-based partnerships which involve the collaboration in research, development, and clinical/commercial manufacturing of pharmaceutical products. As an integrated contract service provider, AustarPharma offers our customers Turn-key solutions ranging from technology development to cGMP commercial manufacturing.

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