Job Summary

A staffing and recruitment agency is filling a position for a Virtual Chemistry Manufacturing and Controls Clinical and Regulatory Affairs Consultant.

Individual must be able to fulfill the following responsibilities:

• Help to deliver the CMC sections of relevant IND, BLA, and MAA regulatory submissions
• Act as the CMC regulatory subject matter expert (SME) on the project team

Qualifications for this position include:

• Have written >3 IND/Reg Submissions
• Must have CMC knowledge
• At least 7 years of Reg Affairs experience
• Module 2 and 3 experience
• Bachelor of Science Degree