Global Quality Compliance Expert

7 days ago


Hyderabad, Telangana, India Novartis Full time

Job Overview:

Novartis is seeking a Global Quality Compliance Expert to join our team. In this role, you will be responsible for ensuring the quality and compliance of our products. You will develop and execute global CMC regulatory strategies, lead CMC submission activities, and identify and address content quality and timeline issues for global submissions.

The successful candidate will have a strong background in chemistry, manufacturing, and control, with experience in regulatory compliance, risk assessment, and risk management. They will possess excellent leadership skills, with the ability to initiate and lead Health Authority interactions and negotiations.

Responsibilities:

  • Develop and execute global CMC regulatory strategies
  • Lead CMC submission activities, including planning, authoring, reviewing, and coordination
  • Identify and address content quality and timeline issues for global submissions
  • Prepare and communicate CMC Risk Management Assessments and contingency plans
  • Initiate and lead Health Authority interactions and negotiations


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