Global Regulatory Affairs Professional

14 hours ago


Bharatpur, Rajasthan, India beBeeRegulatoryAffairs Full time ₹ 40,00,000 - ₹ 60,00,000

Job Overview:

We are seeking a skilled Regulatory Affairs Specialist to support end-to-end submissions for global markets.

Key Responsibilities
  • Variation Document Preparation
  • Evaluate post-approval changes in compliance with global regulatory requirements.
  • Compile dossier modules for Lifecycle Management activities.
  • Prepare initial dossiers for global markets, considering regulations from the US, EU, SA, WHO, ANZ, and other countries.
  • Develop regulatory strategies and conduct evaluations of post-approval changes considering ICH and country-specific guidelines.
  • Manage submission workflows and track queries using Veeva Vault RIM.
  • Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
Experience Requirements
  • Minimum 3 years of experience in managing Initial submissions, Variations, and full Lifecycle management deliverables for global markets.
  • Mandatory experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for global markets.
  • Hands-on experience in initial dossier compilation for global markets.
  • Ability to provide Regulatory strategies/Evaluation by performing assessment of post approval changes considering global regulatory requirements.
Benefits
  • Opportunity to work on end-to-end submissions for global markets.
  • Chance to develop regulatory strategies and contribute to Lifecycle Management activities.
  • Cross-functional collaboration with various teams.


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