
Global Regulatory Specialist
8 hours ago
Description:
We are seeking a highly skilled Regulatory Compliance Specialist to support end-to-end submissions for global markets.
The ideal candidate will have experience in managing initial submissions, variations, and full lifecycle management deliverables for the global markets. They will be responsible for preparing variation documents and evaluating post-approval CMC changes in compliance with global regulatory requirements.
Main Responsibilities:
- Variation Documents: Develop variation documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Lifecycle Management (LCM): Contribute to LCM activities by compiling and reviewing CTD dossier modules.
- Initial Dossier Compilation: Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
- Regulatory Strategies: Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
- Variation/Submission Management: Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
- Veeva Vault RIM Utilization: Utilize Veeva Vault RIM to track queries and manage submission workflows.
- Technical Document Review: Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
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