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CMC RA Specialist

Location: Lake Zurich, Illinois Salary: US$40 - US$50 per hour
Sector: R&D, Quality Assurance (QA), Regulatory Affairs, Quality Assurance (QA), R&D, Regulatory Affairs (RA) Type: Contract

Job Title: CMC RA Specialist

Position Location: Greater Chicago Area

Estimated Contract End Date: 12/31/2019

Primary Responsibilities:

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.