Global Regulatory Affairs Expert

1 week ago


Pushkar, Rajasthan, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,40,00,000

Job Overview:

We are seeking a detail-oriented Regulatory Affairs specialist to support end-to-end submissions for global markets.

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 various countries, including US, EU, SA, WHO, ANZ, and other regions.
  • 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 different 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.

Experience Requirement:

  • 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for various countries.
  • Hands-on experience in initial dossier compilation for various countries (Module 2 & 3).
  • Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.



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