My company provides scientific, regulatory and strategic advice on the registration of prescription pharmaceutical medicines, biological medicines, over-the counter medicines and medical devices.
Our day-day activities include:
Reviewing biological, chemistry, pharmaceutical, manufacturing, preclinical (animal) and clinical (human) data packages and preparing gap-analysis reports.
Liaising with industry experts when required e.g. medical writers, preclinical experts, biopharmaceutical experts, librarians.
Providing drug development advise and strategies.
Preparing regulatory submissions (compilation of all research and development data) for the Australian Government to review and evaluate.
Liaising with the Australian Government (Therapeutic Goods Administration) and New Zealand Authority (Medsafe).
Working in collaboration with pharmaceutical companies throughout the process.
Understanding and applying federal and state legislation, regulation and scientific guidelines.
What part of your work inspires you the most? Why do you find it interesting?
The most inspirational aspect of my work is that we enable and facilitate life-saving and positive health changing therapeutic goods to be available to Australians. Some of these medicines are novel breakthrough medicines, some are biotechnologically manufactured and others provide valuable cost saving options to Australia. We regularly liaise with scientists from overseas manufacturing sites and lead scientists at the Therapeutic Goods Administration to resolve questions. We are scientists every day that we are at work.
How did you get to your current role?
My career began as a laboratory scientist (whilst still an undergraduate) at CSIRO working on a vaccine research project involving studying various vaccine models for a particular veterinary disease. Later I worked at an Australian start-up biotech company in a scientific/quality/regulatory role working with the company's key biological entity. Then I worked in the UK as a developmental scientist working on a influenza vaccine. I have also worked in various regulatory affairs roles within the pharmaceutical industry in Australia and later Canada. Then I entered consulting, opening my own consulting business in 2007.
Do you find the skills you learnt during your degree useful and versatile? If so how?
At the time of completing my degree, biotechnology was relatively new and unique degree. UTS encouraged industrial experience and this enabled me to gain employment at CSIRO as an undergraduate and complete my degree part-time. I graduated with my BSc with two years’ work experience.
Throughout my varied career, the core skills gained from my science degree are utilised. For example: scientific knowledge, analytical thinking, technical writing, investigation and research skills, independent thinking, problem-solving, reasoning and decision making. A science degree provides an understanding of the multidisciplinary approach required in all aspects of work, from research to development and commercialisation.