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Regulatory Affairs

2 weeks ago

Bengaluru, Karnataka, India vueverse. Full time ₹ 8,00,000 - ₹ 12,00,000 per year

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.