Regulatory Affairs Manager
Roche
Total years of experience :9 years, 8 Months
I am responsible for:
-Reviewing & compiling dossiers for registration/ re-registration/ variation for sites and products
-Following up actively on all dossier submissions
-Endeavouring constantly to anticipate and respond to regulatory/ technical queries
-Achieving timely market-driven product submissions and registration approvals
-Meeting product re-registration deadlines for marketing authorisation renewals
-Maintaining an informed awareness of regulatory guidelines
-Coordination and communication between the corporate RA team
-Archiving and maintenance of registration related documents & certificates
-Preparation, follow up and revision of new or modified artworks text
-Ensure that Artwork changes are approved & implemented on time to meet MOH commitments and local / corporate compliance guidelines
I am in charge of local manufacturing the Sanofi product in CMO of sanofi in IRAN