Regulatory Affairs CMC Associate III
Regulatory Affairs CMC Associate III Qualifictions: A need exists in Global CMC Regulatory Affairs for a contractor/temporary help to assist with the preparation, planning and tracking of CMC submissions related to registration renewals and critical compliance and supply situations. The individual must possess a chemistry, pharmacy or chemical engineering degree with some industrial experience (~2 years in research, manufacturing or analytical) as well as existing knowledge of MS WORD and Excel. Additional experience with CMC regulations / guidelines is desired. Project Management experience is preferred. Experience with Microsoft Project is a plus. Responsibilties: Tracking and reporting progress of projects against established timelines. Generating routine metrics reports. Corresponding with International Regulatory Offices to track and record CMC submission progress
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