Senior Regulatory Compliance Professional

1 day ago

Tiruppur, Tamil Nadu, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 10,00,000
Global Regulatory Affairs Specialist

We are seeking a detail-oriented professional to support end-to-end submissions for global markets. This role requires exposure to Lifecycle Management, Veeva Vault RIM, and complex Initial and Variation submissions.

  • Key Responsibilities:
  • Prepare documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
  • Contribute to Lifecycle Management activities by helping to compile and review CTD dossier modules.
  • Compile initial dossiers (Modules 2 & 3) for various 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 multiple 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

Experience Requirement:

  • 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
  • Must have experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for various 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 various 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 various countries as per applicable regulatory guidelines.
The ideal candidate will possess excellent analytical and problem-solving skills, with the ability to work independently and collaboratively within a team environment. A strong understanding of global regulatory requirements and experience working with Veeva Vault RIM is essential for this role. We offer a dynamic and supportive work environment that encourages growth and development. If you are a motivated and experienced professional looking to take your career to the next level, we encourage you to apply.

Our Company Values:

We value innovation, collaboration, and customer satisfaction above all else. Our goal is to provide exceptional service to our customers while fostering a positive and inclusive work environment.

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