An accomplished professional with diverse pharmaceutical experience bringing innovative drug products through development and into the marketplace across multiple therapeutic classes. Skilled at formulating and implementing creative regulatory strategies for both small molecules and biologics ensuring that interdisciplinary data conform to regulatory standards. Diverse experience with regulatory submissions including eCTDs, INDs, NDAs, sNDAs, ANDAs, 505(b)2, MAAs, BLAs, post-approval supplements, and annual reports. Direct experience managing promotional review, DDMAC interactions, due diligence activities, and orphan drug applications.
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