PhD · Global Head Regulatory Affairs at QbD Group
Angeles has built her career at the crossroads of science and regulation. From academic research at CNB and CNIC to leadership roles in biotech and global consulting firms like Asphalion, Parexel, Pharmalex, and Scendea, she translates regulatory complexity into action. She has a strong track record of building and scaling teams, and is especially focused on the intersection of data, AI, and regulation to unlock faster healthcare innovation.
Entering Europe after FDA approval? Learn how to manage EU and UK regulatory submissions, authority interactions, and submission timelines efficiently.
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Entering the EU market requires more than approval. Discover the pharmacovigilance, quality, and MAH requirements biotechs must prepare before European launch.
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Scientific Advice is one of the few moments in early development where a biotech can test its assumptions with regulators. Learn how to structure questions, integrate CMC and clinical strategy, and leverage EMA SME support for maximum impact.
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For US biotechs expanding into the EU and UK, successful submission conversion requires early planning, clear ownership, and a structured approach. Learn how to build a reuse map, manage parallel conversion tracks, and avoid late-stage rework.
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Planning EU and UK expansion as a US biotech? Learn which regulatory, clinical and operational decisions matter from day one.
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Orphan strategy decisions go beyond incentives. Learn how regulatory definitions, evidence requirements, timing, and exclusivity across the EU, US, and UK shape early biotech development strategy.
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Early strategic choices define whether a biotech reaches first-in-human smoothly. Learn how EU/UK regulatory, CMC and quality decisions shape success.
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