Senior Regulatory Specialist

2 weeks ago

Vizag, Andhra Pradesh, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,20,00,000
Regulatory Affairs Specialist Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to support end-to-end submissions for global markets. The successful candidate will have exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.

About the Role:
  • The position involves preparing Variation documents and/or evaluating post-approval CMC changes in compliance with global regulatory requirements.
  • The selected individual will contribute to Lifecycle Management (LCM) activities by helping to compile and review CTD dossier modules.
  • Responsibilities include compiling initial dossiers (Modules 2 & 3) for various countries including the US, EU, SA, WHO, ANZ, and other regions.
  • The role requires providing regulatory strategies and conducting evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
  • The successful candidate will manage compilation and submission of variations/supplements for different countries including the US, EU, SA, WHO, ANZ, and others.
  • Veeva Vault RIM will be utilized to track queries and manage submission workflows.
  • The individual will also review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.
Requirements:
  • A minimum of 3 years of experience in managing Initial submissions, Variations, and full LCM (Lifecycle management) deliverables for global markets.
  • Prior experience with Veeva Vault RIM is mandatory.
  • The ideal candidate should be proficient in ICH guidelines and regulatory guidelines for various countries.
  • Hands-on experience in initial dossier compilation for various countries (Module 2 & 3) is required.
  • Experience in providing Regulatory strategies/Evaluation by performing assessment of post-approval CMC Changes considering global regulatory requirements is essential.

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