Regulatory Compliance Professional

3 days ago


Kozhikode, Kerala, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 15,00,000

Regulatory Affairs Specialist

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

The ideal candidate will have experience in managing initial submissions, variations, and full lifecycle management deliverables for global markets.

The successful candidate will be responsible for preparing variation documents, evaluating post-approval changes, and compiling technical documents from manufacturing sites.

Key Responsibilities:

  • Prepare Variation documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management activities 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 validations, batch analysis data, and stability data.

Experience Requirements:

  • 3+ years of experience in managing initial submissions, variations, and full lifecycle management 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 and review of technical documents from manufacturing sites.
  • Experience in providing regulatory strategies and evaluation of post-approval CMC changes.
  • Compilation and submission of variations/supplements for various countries as per applicable regulatory guidelines.


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