Senior Regulatory Affairs Specialist

5 days ago

Cochin, Kerala, India beBeeRegulatory Full time ₹ 17,00,000 - ₹ 21,47,483

Position Overview:

We are seeking a detail-oriented professional to support end-to-end submissions for global markets. Required expertise 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 US / EU / SA / WHO / ANZ / Other Countries.
  • 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 US/EU/SA/WHO/ANZ/Other 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:
  • 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for the global markets.
  • Must have experience with Veeva Vault RIM
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ ANZ/Other countries.
  • Review of technical documents from manufacturing sites like Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc. required for compilation of dossier sections/Variations.
  • Hands on experience in initial dossier compilation for US/EU/SA/WHO/ ANZ/Other 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 US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.

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