Regulatory Affairs (Veeva-Vault RIM)

Position Overview :

We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.

Key responsibilities :

• Prepare Variation documents and / or evaluate post-approval CMC changes in compliance with global regulatory requirements.
• Contribute to Lifecycle Management (LCM) activities by helping to compile and review CTD dossier modules.
• Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
• Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
• Manage compilation and submission of variations / supplements for US / EU / SA / WHO / ANZ / Other countries.
• Utilize Veeva Vault RIM to track queries and manage submission workflows.
• Review technical documents from manufacturing sites, including :
• Specifications
• Batch Manufacturing Records
• Process & Analytical Validations
• Batch Analysis Data
• Stability Data

Experience Requirement :