
Global Compliance Expert
1 day ago
We are seeking a detail-oriented Regulatory Affairs Associate to support end-to-end submissions for global markets.
- Prepare Variation documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Contribute to Lifecycle Management activities by compiling and reviewing CTD dossier modules.
- Compile initial dossiers (Modules 2 & 3) for various countries, including the US, EU, SA, WHO, ANZ, and others.
- 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 multiple countries.
- Utilize Veeva Vault RIM to track queries and manage submission workflows.
- Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
Required Skills and Qualifications:
- At least 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 multiple countries (Module 2 & 3).
- Experience in providing Regulatory strategies/Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.
- Compilation and submission of Variations/ supplements for various countries as per applicable regulatory guidelines.
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