
Global Regulatory Compliance Specialist
2 days ago
Regulatory Affairs Associate
We are seeking a diligent and experienced Regulatory Affairs professional to support end-to-end submissions for global markets.
Key Responsibilities:
- Prepare variation documents, evaluate post-approval CMC changes, and maintain 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.
- Develop regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
- Manage compilation and submission of variations/supplements for various 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.
Experience Requirements:
- At least 3 years of experience in managing initial submissions, variations, and full lifecycle management deliverables for global markets.
- Must have experience with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory guidelines for various countries.
- Review of technical documents from manufacturing sites is required for compilation of dossier sections/variation.
- Hands-on experience in initial dossier compilation for various countries (Module 2 & 3).
- Experience in providing regulatory strategies/evaluation by performing assessments 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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