Regulatory Affairs Professional

2 days ago


Rajkot, Gujarat, India beBeeRegulatory Full time US$ 90,000 - US$ 1,27,000
Regulatory Compliance Specialist

Job Overview:

We are seeking a detail-oriented Regulatory Compliance Specialist to support global market submissions.

Key responsibilities include preparing regulatory documents and evaluating post-approval changes in compliance with international guidelines.

  • Compile initial dossiers for various countries, including US, EU, SA, WHO, and ANZ.
  • Contribute to Lifecycle Management activities by reviewing dossier modules.
  • Provide regulatory strategies and evaluate post-approval changes considering ICH and country-specific guidelines.

Requirements:

  • 3+ years of experience in managing Initial submissions, Variations, and full Lifecycle management deliverables for global markets.
  • Proficient in ICH guidelines and regulatory requirements.
  • Hands-on experience in initial dossier compilation for global markets.

Benefits:

The ideal candidate will have strong analytical skills, attention to detail, and excellent communication skills.



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