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▷ (Only 24h Left) Regulatory Affairs (Veeva-Vault RIM)

▷ (Only 24h Left) Regulatory Affairs (Veeva-Vault RIM)

vueverse.Bengaluru, Karnataka, India
5 hours ago
Job description

Position Overview :

We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), 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 (LCM) 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

Experience Requirement :

  • 3+ years of experience in managing Initial submissions, Variations, and full LCM (Lifecycle management) 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 of 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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    Only Left Regulatory • Bengaluru, Karnataka, India