Zaklina Buljovcic, PhD Pharmalex

Zaklina Buljovcic, PhD

Zaklina Buljovcic, PhD Pharmalex

Zaklina is biologist by training and working in the Regulatory Affairs business for about 14 years.

Dr. Buljovcic has over 10 years’ experience as a specialist in Regulatory Strategy for Advanced Therapy Medicinal Products respectively Tissue, Cell and Gene Therapies. She also has profound experience and knowledge with various other innovative products such as biologicals, blood products, microbiota transplantation, and a background in veterinary products and medical devices/combination products.

Her main focus areas are strategic and scientific advice, program management and pharmaceutical quality.

Dr. Buljovcic is managing and leading projects within interdisciplinary teams consulting Biotech (mostly SME) and big pharma companies as well as clinics on topics such as Regulatory, CMC and Clinical Development and Scientific Advices, providing regulatory support with early development programs (PRIME, Adaptive Pathway, EAMS and for ATMPs hospital exemption) and strategic market approval processes (accelerated and conditional approval, EU and US), up to central Marketing Authorisations.

She has a profound network within Pharmaceutical Associations and Regulatory Authorities, giving regular presentations and workshops.