Details: Looking for Experienced Clinical Regulatory Affairs Specialist with Pharmaceutical Industry experience on both coasts Duties: Development and maintenance of PMA submission trackers through the PMA lifecycle Management development of submission documents with specific subteams Review documents Provide regulatory guidance to Subject Matter Experts(SMEs)/Authors Assist authors in prioritizing and resolving reviewer comments Review/approval of labels and reports in EtQ Preparation of PMA subtext outlines using Novstyle templates. Authoring documents in NovStyle Assembly and preparation of attachments/appendices/references FDA/CDRH E-sub formatting
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