Regulatory affairs and GMP certified professional experienced in U.S. Food and Drug Administration (FDA) GXPs, product development, regulatory strategy and regulatory submissions. Knowledge of the Defense Federal Acquisition regulations (DFARs) as they pertain to the acquisition of FDA approved/licensed drugs, biological and medical devices. Experienced as an auditor for ISO, ICH and FDA quality systems; Contracting Officer's Representative (COR); FDA regulatory compliance Subject Matter Expert (SME) on DoD Integrated Project Teams (IPTs), and on Source Selection Evaluation Boards (SSEBs).
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