Global Regulatory Affairs Expert

2 days ago


Ajmer, Rajasthan, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000
Regulatory Compliance Specialist

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

Key Responsibilities:

  • Regulatory Document Preparation: Prepare regulatory documents and/or evaluate post-approval changes in compliance with global regulatory requirements.
  • Lifecycle Management: Contribute to lifecycle management activities by helping to compile and review CTD dossier modules.
  • Initial Dossier Compilation: Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
  • Regulatory Strategies: Provide regulatory strategies and conduct evaluations of post-approval changes considering ICH and country-specific guidelines.
  • Submission Management: Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
  • Query Tracking and Workflow Management: Utilize Veeva Vault RIM to track queries and manage submission workflows.
  • Document Review: Review technical documents from manufacturing sites, including Specifications, Batch Manufacturing Records, Process & Analytical Validations, Batch Analysis Data, and Stability Data.

Requirements:

  • Regulatory Compliance Specialist or equivalent qualification.
  • Excellent communication and project management skills.
  • Strong attention to detail and organizational skills.
  • Familiarity with global regulatory requirements and guidelines.


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