Regulatory Project Manager, Delivery Lead, GRA Vaccine CMC MP - Poznan

Tylko dla zarejestrowanych użytkowników Poznan, Polska

1 tydzień temu

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W pełnym wymiarze godzin

Job summary

The CMC Mature Vx Delivery Lead plays a critical role in supporting registered vaccines products by managing complex CMC submissions (such as CMC Post-approval variations, Health Authorities consultations or responses to Health Authorities questions). This includes addressing regulatory requirements for Active Pharmaceutical Ingredients, Intermediates, and Drug Products across global markets.

Responsibilities

- Take ownership for multiple complex CMC regulatory submissions
- Manage multiple project assignments simultaneously
- Identify risks associated with submission data and information package,
  • Take ownership for multiple complex CMC regulatory submissions
  • Manage multiple project assignments simultaneously

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