Compliance Manager

6 days ago

Thāne, Maharashtra, India beBeeRegulatory Full time ₹ 50,00,000 - ₹ 75,00,000
Regulatory Affairs Specialist Job Description

We are seeking a detail-oriented Regulatory Affairs Specialist to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management, Veeva Vault RIM, and complex Initial and Variation submissions.

Key Responsibilities:

  • 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 various countries, ensuring compliance with ICH and country-specific guidelines.
  • Provide regulatory strategies and conduct evaluations of post-approval CMC changes, considering ICH and country-specific regulations.
  • Manage compilation and submission of variations/supplements for multiple countries, adhering to applicable regulatory guidelines.
  • Utilize Veeva Vault RIM to track queries and manage submission workflows.
  • Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
Experience Requirements

At least 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets is required.

The ideal candidate will have hands-on experience in initial dossier compilation for various countries and review of technical documents from manufacturing sites.

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