Director global CMC
SIRE
Utrecht, The Netherlands
19 dagen geleden

The company

Our client is a professional Pharmaceutical organization, based in Utrecht Netherlands. The client is a international pharmaceutical company

Role description

As the director global CMC you are responsible for the regulatory strategy and bring it line with the global strategy. Your main tasks are related to antibodies and vaccines that are in clinical stage and post market.

Responsibilities

  • You are responsible for a group of 8 people and have 3 managers directly reporting to you. You guide the group with interpretations and application of regulations;
  • you help prepare the clinical trial applications; you are the point of contact for third parties and authorities.

    Requirements

  • MSc degree in pharmacy, chemistry or biology
  • Strong affinity with monoclonal antibodies
  • Knowledge of vaccines is a big plus
  • Direct regulatory experience in biotech products a great plus
  • EU and FDA regulation knowledge
  • Team player attitude that keeps his colleagues in mind
  • Leader with clear communication skills
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