Regulatory Affairs

2 weeks ago

Bengaluru, India vueverse. Full time

Position Overview:We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes 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:SpecificationsBatch Manufacturing RecordsProcess & Analytical ValidationsBatch Analysis DataStability DataExperience Requirement: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 RIMProficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ ANZ/Other countries.Review of technical documents from manufacturing sites like of Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc. required for compilation of dossier sections/Variations.Hands on experience in initial dossier compilation for US/EU/SA/WHO/ ANZ/Other 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 US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.

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