
Global Regulatory Affairs Professional
1 day ago
We are seeking a detail-oriented professional to support end-to-end submissions for global markets.
- Key Responsibilities:
- Prepare and evaluate post-approval CMC changes in compliance with regulatory requirements globally.
- Contribute to lifecycle management by helping to compile and review dossier modules.
- Compile initial dossiers (Modules 2 & 3) for various countries, including the US, EU, SA, WHO, ANZ, and other regions.
- Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH guidelines and country-specific regulations.
- Manage submission workflows and track queries using Veeva Vault RIM.
- Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process validations, batch analysis data, and stability data.
Requirements:
- At least 3 years of experience in managing initial submissions, variations, and lifecycle deliverables for global markets.
- Must have experience with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory requirements for various countries.
- Hands-on experience in initial dossier compilation for various countries (Module 2 & 3).
- Experience in providing regulatory strategies by performing assessments of post-approval CMC changes.
Benefits:
- Opportunity to work on end-to-end submissions for global markets.
- Chance to develop expertise in regulatory compliance and lifecycle management.
- Professional growth and development opportunities.
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