Maria joined Commercial Eyes in 2017 and leads the Regulatory Services team. She has extensive experience in regulatory affairs gained through a number of regulatory and manufacturing roles in global pharmaceutical companies working in head office and local affiliate environments, and at Commercial Eyes.
Maria is responsible for multiple teams within Regulatory Services supporting clients with new product applications, life-cycle maintenance and compliance activities for prescription, over-the-counter, and complementary medicines and medical devices, as well as support with cosmetics, food products and quality management systems. Over the past 12 months the regulatory team have completed over 140 projects across a diverse range of therapies (or products…).
Maria has extensive experience in developing regulatory strategies and providing insightful regulatory advice to a variety of stakeholders to support new product launches, commercial objectives and maintain regulatory compliance. She has lead the preparation of a large number of prescription medicine applications for biological products and pharmaceuticals in Australia and New Zealand in a variety of therapy areas. Maria has also been involved in the preparation, review and assessment of regulatory documentation at all stages of the development cycle as well as TGA and Medsafe meetings.
Maria has an undergraduate qualification in Science and a master’s degree in business administration.
When she is not at work, Maria enjoys travelling to new places and has recently returned from a trip to the Baltics.