CMC Regulatory Expert

17 hours ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Key Responsibilities:

The ideal candidate will be responsible for finalizing CMC regulatory strategies for assigned products, including biological products.

  • Develop and execute regulatory strategies by leading the development, review and approval of CMC submission components and documentation.
  • Lead change control evaluation, preparation and submission of CMC dossiers for life-cycle changes to commercial products.
  • Aid in the development and execution of global product and project regulatory strategy(s) by ensuring robust assessment of CMC changes.
  • Provide regulatory leadership as needed to support compliant execution of change management.

Requirements:

  • Bachelor's / Master's / Ph. D. degree in science/ any life sciences discipline.
  • 10+ years of experience in CMC registration and Pre & post approval submission activities.
  • Strong experience in critically reviewing supporting documents and data to ensure adequacy for submission.

About This Opportunity:

We value innovative solutions and complex problem-solving skills.

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