Global Regulatory Specialist

1 day ago

Shimoga, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 10,00,000 - ₹ 15,00,000
Regulatory Affairs Specialist

We are seeking a detail-oriented professional to support global submissions. The ideal candidate will have experience with lifecycle management, Veeva Vault RIM, and complex initial and variation submissions.

  • Prepare variation documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to lifecycle management activities by compiling and reviewing CTD dossier modules.
  • Compile initial dossiers for US/EU/SA/WHO/ANZ/Others.
  • 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 global markets.
  • Utilize Veeva Vault RIM to track queries and manage submission workflows.
  • Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.

Requirements:

  • Minimum 3 years of experience in managing initial submissions, variations, and full lifecycle management deliverables for global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Others.
  • Review of technical documents from manufacturing sites required for compilation of dossier sections/variations.
  • Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Others (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 global markets as per applicable regulatory guidelines.

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