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Associate Director NC Open (J#28074) Title: Associate Director Company: AAI Pharma Education Level: Bachelor's Degree Status: Full Time, Employee Job Category: Biotech/R&D/Science Location: Wilmington, NC 28405 Education Level: Bachelor's Degree Relevant Work Experience: 10 to 15 Years AAIPharma is a leading international provider of pharmaceutical and biotechnology product development services. Our employees work in state-of-the-art facilities using leading edge technologies to meet exciting drug development challenges. We are seeking highly qualified individuals for the following position based in Wilmington, NC: Associate Director, Regulatory Affairs The Associate Director will direct the Wilmington-based Regulatory Affairs group and be "hands-on" particularly in the compilation and submission of chemistry, manufacturing and controls (CMC) documentation for NDAs, ANDAs and other regulatory filings. Will interact with the FDA and clients on regulatory matters; provide regulatory support for internal and external project teams; review and evaluate specifications, test methods, batch records, change controls, deviations, investigations, protocols, and other documents for regulatory compliance, approval and submission; release clinical supplies; monitor compendia updates; maintain approved applications filing 15-day field alerts, label changes, adverse events reports, annual reports, etc. More...

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