
Senior Regulatory Affairs Specialist
7 days ago
Global Regulatory Affairs Specialist
We are seeking a detail-oriented professional to support end-to-end submissions for global markets. The ideal candidate will have exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.
Key Responsibilities:- Document Preparation: Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Lifecycle Management: Contribute to LCM activities by helping to compile and review CTD dossier modules.
- Initial Dossiers: Compile initial dossiers (Modules 2 & 3) for various countries, including the US, EU, SA, WHO, ANZ, and others.
- Regulatory Strategies: Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
- Submission Management: Manage compilation and submission of variations/supplements for various countries.
- Query Management: Utilize Veeva Vault RIM to track queries and manage submission workflows.
- Technical Review: Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
- A minimum of three years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
- Familiarity with Veeva Vault RIM and proficiency in ICH guidelines and regulatory requirements for various countries.
- Hands-on experience in compiling and reviewing technical documents from manufacturing sites, including specifications, batch manufacturing records, and other relevant documents.
- Strong understanding of global regulatory requirements and ability to provide regulatory strategies and evaluations of post-approval CMC changes.
The successful candidate will possess excellent communication and project management skills, with the ability to work effectively in a team environment.
Additional details will be discussed during the interview process.
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