Regulatory Affairs Professional

1 day ago


Aligarh, Uttar Pradesh, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000

Job Title:

Regulatory Affairs Professional

Overview:

We are seeking a skilled Regulatory Affairs 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 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
  • Stability Data

Required Skills and Qualifications:

  • A minimum of 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
  • Mandatory experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for various countries.
  • Review of technical documents from manufacturing sites is required for dossier section/Variation compilation.
  • 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 multiple countries as per applicable regulatory guidelines.

Additional Requirements:

Please note that experience in a similar role or field is an asset. We also encourage applicants to highlight any relevant certifications or training.



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