Senior Regulatory Compliance Professional

4 days ago

Tiruppur, Tamil Nadu, India beBeeRegulatory Full time ₹ 5,00,000 - ₹ 10,00,000

Regulatory Affairs Specialist

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

Key Responsibilities:

  • Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management (LCM) activities by helping to compile and review 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 (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.

Additional Information:

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