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Regulatory Affairs Position

3 weeks ago

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Regulatory Affairs Specialist

We are seeking a detail-oriented 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 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 multiple regions.
  • 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:

As a Regulatory Affairs Specialist, you will be responsible for preparing Variation documents and evaluating post-approval CMC changes in compliance with global regulatory requirements. You will also contribute to Lifecycle Management activities by helping to compile and review CTD dossier modules.

Experience Requirement:

At least 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets. Proficient in ICH guidelines and regulatory guidelines for various countries.