AZ required regulatory submission for Arimidex after trials yielded results supporting new indication for use in early breast cancer. Appointed to lead US & UK Clinical Submissions Team. Developed project plan & defined milestones; assembled project team; represented clinical on cross-functional Product Team; reviewed & commented on clinical, regulatory & pre-clinical documents for NDA & MAA; and managed clinical submissions. We succeeded in delivering documentation & securing NDA approval in record time.
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