Regulatory Affairs Specialist

5 days ago

Malappuram, Kerala, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 1,50,00,000
Job Overview

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

This role will be responsible for preparing Variation documents, evaluating post-approval CMC changes, and contributing to Lifecycle Management activities.

  • Prepare Variation documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management by compiling and reviewing CTD dossier modules.
  • Compile initial dossiers for various countries, including the US, EU, SA, WHO, ANZ, and others.
  • 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 various 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.
Required Skills and Qualifications
  • Minimum 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.
  • Review of technical documents from manufacturing sites required for dossier sections/Variations.
  • 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.
  • Compilation and submission of Variations/supplements for various countries as per applicable regulatory guidelines.

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