Regulatory Affairs Specialist

6 days ago


Nashik, Maharashtra, India beBeeregulatory Full time ₹ 1,20,00,000 - ₹ 1,40,00,000
Regulatory Affairs Position Overview

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

  • Prepare variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to lifecycle management 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

Key Responsibilities:



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