Manager Regulatory Affairs And Cmc
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CARBOGEN AMCIS
Bubendorf
Your responsibilities: - Reviewing and maintaining registration documents (Drug Substance CMC Quality Module / sections for INDs, IMPDs, BLAs and MAAs) in accordance with the requirements of the authorities and customers requirements as well as international guidelines. - Assisting with the submission of post-approval change documentation. - Regulatory assessment in terms of change management... |
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vor 5 Tagen
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