Aleksandra Zvezdakoski

With a rich background in regulatory affairs, Aleksandra has accrued invaluable experience during her tenures at GlaxoSmithKline and Pfizer, as well as through her consulting ventures. She specialises in providing comprehensive support for a wide array of pharmaceutical applications, including New Chemical Entities (NCEs), generics, and Over the Counter (OTC) medicines.

Her expertise extends to navigating regulatory frameworks, including Project Orbis applications, and overseeing project coordination and post-marketing activities. Aleksandra’s knowledge in ensuring compliance with Good Manufacturing Practice (GMP) standards for both local and international manufacturers, along with her proficiency in PIC/S guidelines for medicinal products, underscores her commitment to quality and regulatory excellence.

Moreover, Aleksandra has gained firsthand insights into clinical trial operations as a clinical research coordinator in Australia. This role has equipped her with a nuanced understanding of trial conduct from a site perspective, as well as adeptness in managing associated quality systems.

Having completed the Medicines Australia Code of Conduct (Program 1) certification through the University of Tasmania in 2023, Aleksandra has the experience and skillset to perform the regulatory review of promotional materials for healthcare professionals and patients, used in educational and/or public domains.

Recognised for her exceptional communication skills and project management abilities, Aleksandra excels in her role in Business Development. As a great communicator, she builds strong rapport with clients and stakeholders, fostering lasting relationships built on trust and mutual understanding. Her proficiency as a great project manager enables her to effectively coordinate initiatives, ensuring timely execution and delivery of objectives.

Aleksandra holds a Biotechnology and Cell Biology and has graduated with first-class Honours in microbial genetics from La Trobe University, Australia.