Regulatory Affairs (Veeva-Vault RIM)

Position Overview: We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includesLifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities: PrepareVariation documents and/or evaluate post-approval CMC changesin compliance with global regulatory requirements. Contribute toLifecycle Management (LCM) activitiesby helping to compile and review CTD dossier modules. Compile initial dossiers(Modules 2 & 3)forUS / EU / SA / WHO / ANZ / Other Countries . Provide regulatory strategies and conduct evaluations of post-approval CMC changes consideringICHand country-specific guidelines. Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries. UtilizeVeeva Vault RIMto track queries and manage submission workflows. Review technical documents from manufacturing sites, including: Specifications Batch Manufacturing Records Process & Analytical Validations Batch Analysis Data Stability DataExperience Requirement: 3+ years of experience in managingInitial submissions ,Variations , and fullLCM (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. 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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