
Global Regulatory Affairs Specialist
7 days ago
Regulatory Affairs Professional
We are seeking a highly skilled Regulatory Affairs Associate to support our end-to-end submissions for global markets. The successful candidate will have exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.
Key Responsibilities:
Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
Contribute to Lifecycle Management (LCM) activities by helping to compile and review CTD dossier modules.
Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
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 US/EU/SA/WHO/ANZ/Other countries.
Utilize Veeva Vault RIM to track queries and manage submission workflows.
Review technical documents from manufacturing sites, including:
Specifications
Batch Manufacturing Records
Process & Analytical Validations
Batch Analysis Data
Stability Data
Requirements:
Minimum 3+ years of experience in managing Initial submissions, Variations, and full LCM (Lifecycle management) deliverables for the global markets.
Must have experience with Veeva Vault RIM.
Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
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