Global Regulatory Compliance Specialist

2 days ago


Vadodara, Gujarat, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 15,00,000

Regulatory Affairs Associate

We are seeking a diligent and experienced Regulatory Affairs professional to support end-to-end submissions for global markets.

Key Responsibilities:

  • Prepare variation documents, evaluate post-approval CMC changes, and maintain compliance with global regulatory requirements.
  • Contribute to lifecycle management activities by compiling and reviewing CTD dossier modules.
  • Compile initial dossiers (Modules 2 & 3) for various countries.
  • Develop regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
  • Manage compilation and submission of variations/supplements for various countries.
  • 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.

Experience Requirements:

  • At least 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 various countries.
  • Review of technical documents from manufacturing sites is required for compilation of dossier sections/variation.
  • Hands-on experience in initial dossier compilation for various countries (Module 2 & 3).
  • Experience in providing regulatory strategies/evaluation by performing assessments of post-approval CMC changes considering global regulatory requirements.
  • Compilation and submission of variations/supplements for various countries as per applicable regulatory guidelines.


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