Global Regulatory Affairs Specialist

1 day ago


Coimbatore, Tamil Nadu, India beBeeRegulatory Full time ₹ 6,00,000 - ₹ 10,00,000

Job Title: Regulatory Affairs Specialist

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

  • The ideal candidate will have experience in managing Initial submissions, Variations, and full Lifecycle management deliverables for the global markets.

About the Role:

The Regulatory Affairs specialist will be responsible for preparing Variation documents and/or evaluating post-approval CMC changes in compliance with global regulatory requirements.

  • Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
  • 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 US/EU/SA/WHO/ANZ/Other countries.

Key Responsibilities:

  • 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:

  • 3+ years of experience in managing Initial submissions, Variations, and full Lifecycle management deliverables for the global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
  • Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.


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