Detail-Oriented Regulatory Expert

3 days ago


Guntur, Andhra Pradesh, India beBeeRegulatoryAffairs Full time ₹ 10,00,000 - ₹ 15,00,000
Regulatory Affairs Associate

We are seeking a detail-oriented professional 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.

Key Responsibilities:
  • Prepare variation documents and/or evaluate post-approval changes in compliance with global regulatory requirements.
  • Contribute to lifecycle management activities by compiling and reviewing CTD dossier modules.
  • Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
  • Provide regulatory strategies and conduct evaluations of post-approval changes considering ICH and country-specific guidelines.
  • Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
  • Utilize Veeva Vault RIM to track queries and manage submission workflows.
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.
  • Review of technical documents from manufacturing sites like Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc. required for compilation of dossier sections/Variations.
  • 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.
  • Compilation and submission of Variations/supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.

This is an excellent opportunity to join our team and take your career to the next level.



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