Global Regulatory Specialist

2 weeks ago


Bhavnagar, Gujarat, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 18,00,000

Job Title:

Global Regulatory Specialist

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

  • Develop regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
  • Compile and manage submission workflows using Veeva Vault RIM, tracking queries and ensuring compliance with regulatory requirements.
  • Review technical documents from manufacturing sites, including specifications, batch manufacturing records, process and analytical validations, batch analysis data, and stability data.

Requirements:

  • Minimum 3 years of experience in managing Initial submissions, Variations, and full LCM (Lifecycle management) deliverables for the global markets.
  • Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
  • 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.

Preferred Qualifications:

  • Experience with Veeva Vault RIM and regulatory software.
  • Strong understanding of lifecycle management and regulatory processes.

What We Offer:

  • Opportunities for growth and professional development.
  • Collaborative and dynamic work environment.

How to Apply:

  1. Submit your application through our website.
  2. Include your resume, cover letter, and relevant certifications.


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