Dr Daina Vanags

REGULATORY AFFAIRS

Dr Daina Vanags, Regulatory Expert

Daina has over 20 years experience in scientific research and biopharmaceutical product development and pharmaceutical consulting services in Australian, EU and US regulatory affairs.

Daina has a range of skills including executive management in the biotechnology industry (listed and unlisted companies), management of preclinical and clinical studies, intellectual property, quality control and bioanalytical assay development (PK, PD and immunogenicity) across various therapeutic areas.

She has regulatory affairs and strategic product development experience in Australia, NZ, USA, Europe and India providing scientific, regulatory support including regulatory strategy, gap analyses, authoring of IB, IMPD, pre-IND, IND, nonclinical dossier sections, Scientific Advice and registration dossiers. Interactions with and presentations to regulatory agencies including US FDA, EMA, TGA, CDSCO and presenting training workshops in Regulatory Affairs.