Mirna Elbadry
Regulatory Site Officer at Sanofi
- Role
- Regulatory Site Officer at Sanofi
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Mirna Elbadry
Regulatory Affairs professional with a Master’s degree in Regulatory affairs;…
Experience
Regulatory Site Officer
Oct 2022 — Present · MA, US
Regulatory Compliance • Ensures that the CMC dossier is in line with manufacturing and control procedures on site and with the corresponding dossiers approved by Health Authorities • CMC Documentation management (CMC Author) • Manages, coordinates and ensures the writing of CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submission including answers to questions from Health Authorities • Supports product licenses maintenance and site registrations: supports Marketing Authorizations worldwide (renewals, site registrations and transfers…) by ensuring the writing of the corresponding CMC documents/dossiers and collecting GMP related documents from the site. · Contributes to site inspections and audits · Planning, tracking and reporting of regulatory activities/ approvals to the Regulatory Site manager as well as to the different project managers
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