
Regulatory Affairs Specialist
6 days ago
We are seeking a detail-oriented regulatory affairs professional to support end-to-end submissions for global markets.
- Prepare variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Contribute to lifecycle management 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
Key Responsibilities:
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