Senior Regulatory Affairs Specialist

2 days ago

Surat, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 20,00,000

Job Summary:

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

This role requires the ability to manage lifecycle management, Veeva Vault RIM, and complex initial and variation submissions.

Main Responsibilities:
  • Prepare Variation documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management activities by helping to compile and review CTD dossier modules.
  • Compile initial dossiers (Modules 2 & 3) for various countries, including the US, EU, SA, WHO, ANZ, and other regions.
  • 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 multiple 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.
Required Skills and Qualifications:
  • 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 required for compilation of dossier sections/Variations.
  • 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 for various countries as per applicable regulatory guidelines.

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