Regulatory Affairs Specialist

2 days ago


Jamnagar, Gujarat, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000

Regulatory Affairs Specialist

Job Overview

The Regulatory Affairs Associate will support end-to-end submissions for global markets, focusing on Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.

  • 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, and Stability Data.
Requirements
  • 3+ years of experience in managing Initial submissions, Variations, and full LCM 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).
  • Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.

This role requires a strong understanding of regulatory affairs principles and practices. If you are passionate about ensuring product safety and compliance, we encourage you to apply.



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