Regulatory Affairs Associate
Edison-New Brunswick Metro Area, NJ
Under supervision, performs the preparation, review and submission of pre and post-approval CMC submissions to the Food and Drug Administration, using governmental guidelines and regulations.
Bachelor's degree in chemistry or related field from an accredited college or university, and five (5) years work experience in the pharmaceutical industry or three (3) years of satisfactory performance as a Regulatory Affairs Associate II. Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels. Work is performed in an office environment.