Harmony Labs Jobs in North Carolina
Job Description Title: Sr. Manager of Regulatory Affairs JOB SUMMARY The Sr. Manager, Regulatory Affairs will support the business by providing sound regulatory strategy and timely compilation of Chemistry, Manufacturing, and Controls (CMC)Technical Sections of regulatory submissions related to branded and generic drug submissions. The successful candidate will assess post-approval changes and ...
Tests and documents samples of raw materials, in process, finished and stability samples, water and other samples provided by various departments to help ensure quality in the manufacturing process. Perform suitability testing/method development for new products to include writing of protocols, execution and final report Perform USP (USP,) limits testing on samples Perform AET (USP, and EP 5.1....
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