Anna Hanzlíková

Senior Director, Global RA, Regulatory Head, Europe and ROW at NOVAVAX CZ a.s.

Speaker

Anna Hanzlikova holds an M.D. title from 1st Faculty of Medicine at Charles University in Prague. She explored and gained experience at several positions in project management, marketing and for the last 16 years in global regulatory affairs, at regional or global level, with responsibility for various regions.

Anna started her regulatory career at Sanofi, Generics division, which gave her an opportunity to understand practical aspects of country management of Asian, Middle East as well as Latin and South American countries. Her position as Global Regulatory Affairs Director at PRO.MED.CS, a smaller family owned Czech based company with mixture of generics and innovative products, including products of animal origin, brought additional experience with registrations expansion across geographical Europe, Russian speaking countries as well as other regions. In addition to that, she was active as a deputy R&D Director, which added further insights in early development stages of medicinal products, negotiations with suppliers across all regions and refreshed project management skills.

During the peak of pandemic, Anna accepted an offer from Novavax, to take lead in new marketing authorisation efforts for a protein-based Covid-19 adjuvanted vaccine in Europe, Asia and Middle East as well as with WHO. Today, with successful full marketing authorisations in Europe and other regions, she leads part of the global regulatory affairs team at Novavax to cover all life cycle activities of the vaccine as well as participating on the regulatory activities for products under development. She is a member of regulatory working group at Vaccines Europe, a specialised vaccines group within the European Federation of Pharmaceutical Industries and Associations (EFPIA), and is participating actively at events like Vaccines Europe and EMA annual meeting, ICMRA workshop with industry participation etc.

Anna has build and led small to mid sized international regulatory teams, with focus at all – global, regional and affiliate level, and an emphasis on good communication, multicultural diversity, excellence in organisation and successful regulatory tasks delivery. She enjoys working and growing with the team as well as creative work on regulatory strategies or authoring of some regulatory documents.