CMC Regulatory Senior Specialist
Jefferson Wells
Frosinone
21
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Azienda: Jefferson Wells Frosinone
Key Responsibilities: Authoring of CMC sections ( Drug Product and/or Drug Substance) of the registration dossier for new applications in CTD format in line with the Global regulatory strategies and the most current regulatory guidelines Authoring and review of CMC sections to support variations Gap Analysis and/or Due Diligences of Quality Parts of Global Dossier(s) Ensure regulatory compliance of CMC sections of global products and drug substances throughout the product lifecycle Evaluation of regulatory impact of quality change controls Support to QA function during Health Authorities’ inspections Support to QA and Virtual Plant for Third parties Qualification (CMO) Publishing and/or creation of eCTD sequences related to CMC sections Permanent role, within company production site ( Frosinone).
✔ Jefferson Wells