Global Regulatory Affairs Specialist

4 days ago


Varanasi, Uttar Pradesh, India beBeeRegulatoryAffairs Full time ₹ 8,00,000 - ₹ 15,00,000
Job Overview

We are seeking a detail-oriented professional to support end-to-end submissions for global markets.

Main Responsibilities:
  • Lifecycle Management (LCM) Support: Compile and review CTD dossier modules, prepare Variation documents, and evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Initial Dossier Compilation: Assist in compiling initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
  • Veeva Vault RIM Utilization: Track queries and manage submission workflows using Veeva Vault RIM.
  • 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 US/EU/SA/WHO/ANZ/Other countries.
Requirements:
  • 3+ years of experience in managing Initial submissions, Variations, and full LCM (Lifecycle management) deliverables for the global markets.
  • 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 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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