Regulatory Associate

Job description:Assist Regulatory Personnel with the Completion of Work Packages for Development Projects:Draft Meeting Requests and Briefing Packages for FDA meetings, Investigational New Drug Applications, Supplemental Biologic License Applications, Supplements to Marketing Applications (Labeling, Efficacy, and CMC), Pediatric Study Plans, Orphan Drug Applications, Clinical Trial Supporting Documents (Protocol Amendments, Investigator Updates, Investigator's Brochure, harmonization request, IND Safety Reports).Assist Regulatory Personnel with Labeling and Artwork MaintenanceReview and perform quality checks of labeling and artwork updates for all products. Work Location: 6601 Six Forks Road, Raleigh, NC 27615