RA CMC Manager - Gola

Only for registered members Gola, India

1 month ago

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Job summary

The purpose of this role is to execute CMC regulatory activities for new products registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products.

Responsibilities

  • Responsible for CMC regulatory matters relating to registrations and/or life-cycle maintenance of business activities (including variations and renewals) for assigned product portfolio.
  • Preparation of CMC sections of new registration files, PIFs, MDTFs, briefing books, clinical trials applications/INDs,Carefully review the job description to extract relevant information: Job Title: RA CMC Manager - Business Protection & Optimization
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