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Lead business development for existing and prospective life-science clients: identify leads, manage sales through contract closure, create and deliver client presentations, collaborate with proposals, project management, and finance to grow accounts and company visibility.
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Leads strategic and operational regulatory consulting for pharmaceutical and biotech clients from early development through NDA/BLA. Prepares IND, NDA/BLA, orphan drug designation, fast-track, and FDA advice-request documentation; advises clients and internal teams; serves as a client and Health Authority liaison; leads FDA interactions; and supports business development and marketing. Provides technical and supervisory leadership while applying knowledge of ICH GCP, clinical trials, regulatory requirements, and CRO-pharmaceutical relationships.
