Job Title: CMC RA Specialist
Position Location: Greater Chicago Area
Estimated Contract End Date: 12/31/2019
Reviewing technical documents for cGMP and regulatory compliance. Prepare and file A/NDA's, Supplements, and Amendments for sterile injectable products. Support team in any other regulatory activities related to product submissions. Attend team meetings independently.
Specific skills and/or knowledge:
-Bachelor Degree in a scientific discipline
-Minimum 4 years' experience in pharmaceutical Regulatory Affairs or a related role supporting regulatory submissions and FDA deficiency responses
-Experience with full submission lifecycle, specifically the CMC and chemistry portion of the application
-Experience in preparing and filing complete A/NDA's, Supplements and Amendments to FDA
-Thorough understanding of the CFR, FDA/ICH guidelines and cGMP's, as they pertain to pharmaceuticals
-Experience in Sterile Injectables preferred.
-Generic drug experience is preferred
Sthree US is acting as an Employment Business in relation to this vacancy.