Senior Regulatory Affairs Specialist

5 days ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,50,00,000
Regulatory Affairs Specialist

Job Description:

We are seeking a detail-oriented Regulatory Affairs Specialist to support end-to-end submissions for global markets. This role involves exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.

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/Others.
  • 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/Others.
  • 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

Required Skills and Qualifications:

  • Minimum 3 years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
  • Must have hands-on experience with Veeva Vault RIM.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Others.
  • Hands on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Others (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/Others as per applicable regulatory guidelines.

Benefits:

This role offers the opportunity to work with a dynamic team and contribute to the success of our organization.

How to Apply:

Interested candidates should submit their resume and cover letter for consideration.

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