Regulatory Affairs Specialist

2 days ago

Pune, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 12,00,000 - ₹ 20,00,000

Regulatory Affairs Specialist

We are seeking a detail-oriented professional to support end-to-end submissions for global markets.

Responsibilities:

  • Evaluate post-approval changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management activities by helping to compile and review dossier modules.
  • Compile initial dossiers for various countries.
  • Provide regulatory strategies and conduct evaluations of post-approval changes considering ICH guidelines.
  • Manage submission workflows and track queries using Veeva Vault RIM.
  • Review technical documents from manufacturing sites, including specifications, batch records, process validations, and analysis data.

Requirements:

  • 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for the global markets.
  • Must have experience with Veeva Vault RIM and ICH guidelines.
  • Proficient in reviewing technical documents from manufacturing sites and compiling dossier sections.
  • Hands-on experience in initial dossier compilation for various 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 as per applicable regulatory guidelines.

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