Global Regulatory Affairs Expert
1 week ago
Job Overview:
We are seeking a detail-oriented Regulatory Affairs specialist to support end-to-end submissions for global markets.
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 various countries, including US, EU, SA, WHO, ANZ, and other regions.
- 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 different 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, and Stability Data.
Experience Requirement:
- 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
- Must have experience with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory guidelines for various countries.
- Hands-on experience in initial dossier compilation for various countries (Module 2 & 3).
- Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.
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