Global Regulatory Expert

1 week ago

Kolkata, West Bengal, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 13,50,000
Regulatory Affairs Specialist

We are seeking a detail-oriented Regulatory Affairs specialist to support end-to-end submissions for global markets.

The ideal candidate will have experience in managing Initial submissions, Variations, and full Lifecycle Management deliverables for the global markets. They must have hands-on experience with Veeva Vault RIM and proficiency in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.

Key Responsibilities:

  • Prepare Variation documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management (LCM) activities by compiling and reviewing CTD dossier modules.
  • Compile initial dossiers (Modules 2 & 3) for various 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 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, and stability data.

Requirements:

  • 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
  • Hands-on experience with Veeva Vault RIM.
  • Proficiency in ICH guidelines and regulatory guidelines for multiple countries.
  • Experience in reviewing technical documents from manufacturing sites.
  • Strong analytical and problem-solving skills.

This role offers opportunities for professional growth and development in a dynamic environment. If you are a motivated and organized individual with excellent communication skills, we encourage you to apply for this challenging opportunity.

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