Susan is an expert in both ICH and Emerging Markets including market-specific CMC requirements for global markets. Her primary expertise lies in the analytical deliverables needed to support drug product registration in the US, EU, and EMAP markets.
She has extensive knowledge of the technical and regulatory requirements of the analytical content for many dosage form dossiers including instant and modified release solids, soft gels, liquids, suspensions sterile injectables, single entity and fixed dose combinations.
Susan holds a bachelor’s degree in Chemistry from Wake Forest University. She has held analytical positions with increasing levels of responsibility at both Burroughs Wellcome Company and GlaxoSmithKline. Her most recent position held was Director, Emerging Markets R&D where she had oversight of teams in RTP and Singapore. Prior to this position, Susan was a CMC lead for early phase programs.
Examples of projects completed: