Global Regulatory Specialist

2 days ago


Anantapur, Andhra Pradesh, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,00,00,000
Regulatory Affairs Professional

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

  • Lifecycle Management Expertise:
  • Compile and review CTD dossier modules for Lifecycle Management (LCM) activities.
  • Prepare Variation documents and/or evaluate post-approval changes in compliance with global regulatory requirements.

Key Responsibilities:

  • Submission Management:
  • Compile initial dossiers for US/EU/SA/WHO/ANZ/Others, including Modules 2 & 3.
  • Manage submission of Variations/Supplements for global markets.

Requirements:

  • Regulatory Experience:
  • At least 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
  • Proficient in ICH guidelines and regulatory guidelines for global regions.

Competitive compensation package will be offered to the successful candidate.



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