Maria Arce-Tomas
Vice President Global Head of Regulatory Affairs @Nouscom
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WORK HISTORY
Vice President Global Head of Regulatory Affairs @Nouscom
EDUCATION
University of Valencia
MSc Toxicology
Harvard Business School
HBS Novo Nordisk Program
University of Valencia
Bachelor of Pharmacy - BPharm
King's College London
PhD Biochemistry
Cardiff University / Prifysgol Caerdydd
BIRA Diploma in Regulatory Affairs
ABOUT MARIA ARCE-TOMAS
A senior leader in the biopharmaceutical industry with outstanding business, global regulatory affairs and R&D expertise. Driven by integrity, innovation and passion with a resolute focus to deliver value to the patients, business and society. Experienced in leading and managing global and regional regulatory functions and handling negotiations directly with the EMA, FDA, PMDA and other key national agencies. Expertise in cross-functional team leadership, in-licensing and major change management projects. Wide experience of developing, registering and maintaining products including orphan drugs for the treatment of cancer, blood and growth disorders, respiratory diseases and antivirals. Led the development and registration of more than 20 innovative products globally. Strong knowledge base and experience of Business Operations, Corporate Legal & Strategy, Corporate Finance, Quality & Compliance, Business Development & Alliance Management.
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