Global Regulatory Affairs Specialist

1 day ago


Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,50,00,000
Global Regulatory Affairs Specialist

We are seeking a highly motivated and detail-oriented Global Regulatory Affairs Specialist to support the development and implementation of regulatory strategies for global markets.

Key responsibilities include:

  • Develop and implement regulatory strategies to ensure compliance with global regulatory requirements.
  • Contribute to Lifecycle Management (LCM) 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 others.
  • Provide regulatory guidance and conduct evaluations of post-approval 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.

Requirements:

  • Minimum 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for various countries.
  • 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 changes considering global regulatory requirements.
  • Compilation and submission of Variations/ supplements for various countries as per applicable regulatory guidelines.

Additional Requirements:

  • Strong understanding of ICH guidelines and regulatory requirements.
  • Excellent communication and collaboration skills.
  • Able to work in a fast-paced environment with multiple priorities.


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