Beate Sonntag

Regulatory Affairs Consultancy für Humanarzneimittel /Unterstützung bei Zulassungsprojekten

Regulatory Affairs consultancy for dedicated Service in European Regulatory Affairs medicinal product labeling projects, e.g: • Labeling alignment Projects • Labeling organization, processes, policies and tools • Labeling compliance for inspections and audits • Optimization of Core labeling (CCDS or Master SmPC) • Regulatory Intelligence and Trainings

Integration der Global Labeling Organization in die Abbott Prozesse/Organisation bei gleichzeitiger Fortsetzung sämtlicher RA labelling Zulassungsaktivitäten für das gesamte Produktportfolio;

Head of Global Regulatory Affairs Labelling

Head of European Regulatory Affairs Liaison Advise RA management and liaison staff on regulatory affairs topics Acting as the Secretary of the Global Labelling Committee RA integration for business acquisitions (Fournier, Neopharma)