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Sibylle (Billie) Herzer PhD (Cell Biology), Diploma (Genetics)
Senior Director Regulatory CMC
Kite
Amsterdam
Netherlands
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At Kite, leading a team of regulatory scientists and experts in support of Kite’s cell therapy clinical and commercial assets in the EU and EU aligned markets. Submission work from clinical FIH to post approval including scientific advice meeting preparation and attendance. Ensuring compliance with current regulation application to CMC activities, regulatory assessment and implementation of planned CMC changes, and anticipation of risks and preparation of contingency plans. Co-located at the site of manufacture enabling close collaboration with Quality, Manufacturing and Qualified Persons. Feedback and collaboration on emerging regulations of importance to the cell therapy sector. Alliance of Regenerative Medine’s co-chair for the EU.