Associate Regulatory Site Officer

Responsibilities

• As a Associate Regulatory Site Officer you are responsible for managing and reviewing of CMC (Chemistry, Manufacturing and Controls) dossiers, variations, renewals, annual reports, site registrations and territory extensions as part of regulatory product lifecycle management responsibility
• You are responsible for implementing change control updates from our partnered sites into the existing regulatory dossiers and prepare associated regulatory CMC documentation for submission to the authorities, in collaboration with Sanofi experts and external partners
• You are analyzing impact of proposed change controls on the existing regulatory submissions
• You are responsible for reviewing operational documentation/reports in order to ensure compliance with the dossiers

Requirements

• Bachelor or master with scientific background
• CMC background/experience required
• Regulatory background/experience required + experience with major market submissions such as US, EU, Japan, China,…
• Regulatory database (Veeva Vault RIM) experience required
• Previous experience with working at Sanofi is considered highly beneficial
• Good organizational skills
• Attention to details
• Good communicator and project manager
• Proven ability to work across functions and cultures