Global Regulatory Compliance Manager

2 days ago


Allahabad, Uttar Pradesh, India beBeeregulatory Full time ₹ 80,00,000 - ₹ 1,20,00,000
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to support our end-to-end submissions for global markets.

The ideal candidate will have experience in managing Initial submissions, Variations, and full Lifecycle Management deliverables for global markets.

Key Responsibilities:
  • Variation Document Preparation
  • Lifecycle Management Activities
  • Initial Dossier Compilation
  • Regulatory Strategies
  • Submission Management
  • Veeva Vault RIM Utilization
  • Document Review

Experience Requirements:

  • Minimum 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.
  • 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.


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