Global Regulatory Compliance Specialist

2 weeks ago


Nashik, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000
Regulatory Affairs Associate

We are seeking a detail-oriented professional to support end-to-end submissions for global markets.

Key Responsibilities:
  • Lifecycle Management (LCM): Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • CTD Dossier Modules Compilation: Contribute to Lifecycle Management activities by helping to compile and review CTD dossier modules, including initial dossiers for US / EU / SA / WHO / ANZ / Other Countries.
  • Regulatory Strategies: Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
  • Submission Workflow Management: Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries utilizing Veeva Vault RIM to track queries and manage submission workflows.
  • Technical Document Review: Review technical documents from manufacturing sites, including Specifications, Batch Manufacturing Records, Process & Analytical Validations, Batch Analysis Data, Stability Data.
Requirements:
  • Experience: 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for the global markets.
  • Veeva Vault RIM: Must have experience with Veeva Vault RIM.
  • Regulatory Guidelines: Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • Technical Documents: 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.
  • Initial Dossier Compilation: Hands-on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
  • Regulatory Strategies Evaluation: Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements.
  • Variation Submission: Compilation and submission of Variations/supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.


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