Global Regulatory Affairs Expert

1 day ago


Davangere, Karnataka, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 16,00,000
Job Description

As a regulatory affairs specialist, you will play a vital role in ensuring the timely and successful submission of documents to global regulatory authorities. This includes preparing variation documents, evaluating post-approval changes, and managing submissions workflows using Veeva Vault RIM.

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  • Prepare and submit variation documents, including initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
  • Contribute to lifecycle management activities by compiling and reviewing CTD dossier modules.
  • 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.
  • Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process & analytical validations, batch analysis data, and stability data.
Required Skills and Qualifications

The ideal candidate will possess the following skills and qualifications:

  • 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 US/EU/SA/WHO/ANZ/Other countries.
  • Review of technical documents from manufacturing sites 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.


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