Regulatory Affairs Specialist

4 days ago


Meerut, Uttar Pradesh, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000
Regulatory Affairs Professional

Overview:

We seek a detail-oriented Regulatory Affairs Associate to support submissions for global markets. Required expertise includes Lifecycle Management (LCM), Veeva Vault RIM, and complex initial and variation submissions.

Key Responsibilities:

  • Prepare Variation documents and evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to LCM 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 CMC 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.
  • Review technical documents from manufacturing sites, including:
  • Specifications
  • Batch Manufacturing Records
  • Process & Analytical Validations
  • Batch Analysis Data
  • Stability Data
Requirements
  • 3+ years of experience in managing initial submissions, variations, and full LCM 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.
Qualifications
  • Bachelor's degree in a life sciences or related field.
  • Strong understanding of regulatory guidelines and regulations.
  • Excellent communication and project management skills.

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