Regulatory Affairs Associate

Job Title: Labeling Assistant
Duration: 2 Months+
Location : Huntsville, AL

Summary:
Mark up the labeling (container and insert labels) and communicate the changes to the labeling vendor. Proof read the labeling for accuracy and formatting upon receipt from the vendor. Process the final labeling for approval and transmit the approved labeling to the vendor and internally to other groups like QA etc. File the approved labeling per Qualitest procedures and policies.

Job Description:
•    Performs routine cleaning and disinfection operations for the production support and process equipment according to Standard Operating Procedures (SOPs).
•    Prepare the draft labeling and coordinate with the labeling vendors to revise the labeling as directed by the supervisor
•    Proofs read the labeling upon receipt from the labeling vendor for accuracy, formatting and process the final labeling for review and approval internally within Qualitest and communicate the approvals to vendors.
•    Responsible to organize and file labeling files/folders (both electronic and paper based) as per Qualitest procedures and policies.
•    Maintain the log and status reports of labeling activities
•    Prepare side by side comparison of proposed labeling against current approved labeling for submission to the FDA