Fadi Hakki
Associate Vice President & Head of Regulatory Affairs-cmc @Omeros Corporation
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WORK HISTORY
Associate Vice President & Head of Regulatory Affairs-cmc @Omeros Corporation
SKILLS
ABOUT FADI HAKKI
Seasoned professional in the biopharmaceutical industry with over 25 years of experience in the drug development lifecycle of biologics. Result-driven, dynamic, and versatile Regulatory Affairs-CMC professional with extensive practical experience in biopharmaceutical product development and Regulatory Affairs-CMC for biologics. Global Regulatory Affairs-CMC Lead for three commercial products (FASENRA®, UPLIZNA® & TEPEZZA®), and proven performance track with successful submission and approval of Marketing Applications, supplements, and variations across multiple regions. Great managerial skills in team organization and conflict resolution along with a strong scientific background, leadership, integrity, and a bottom-line approach. Successful in managing cross-functional teams and building collaborative relationships between departments and senior management. Furthermore, Fadi has extensive CMC experience in Analytical assay development, Quality Control and Quality Assurance.
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