Regulatory science is the process by which patient/customer safety is maintained by utilising knowledge from various disciplines within a structured and legal framework. It was established from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, biologicals and medical devices.
A shift towards focusing on the “Product Life Cycle” is internationally recognised as the way forward in conducting Regulatory affairs. It is an all-inclusive approach which deals with the science of product development and manufacturing, through to product placement, marketing, distribution and sales activities.
The product life cycle approach will broaden the employment scope for the Regulatory affairs professional as technology and innovation in the health products area continues to evolve and become more complex. In order to safe guard the public into the future, Regulatory Science equally needs to expand to meet these demands to ensure that quality assurance is maintained at every stage of the supply chain.
The Graduate Certificate is suitable for those people who wish to enter a range of health science industries such as Biotechnology, pharmaceutical and complementary medicine manufacturing, as well as current healthcare and other industry professionals wanting to broaden, advance and future proof their career by becoming advocates for maintaining the effectiveness of the product life cycle.
The Graduate Certificate is a pathway for further studies or roles in the growing Biotechnology industry sector.
Career pathways include: regulatory or clinical affairs associates; research or development scientists; marketed-product support, quality assurance roles; biomedical, manufacturing and validation and process control engineers; post market surveillance and vigilance monitoring roles; distribution and legal representation of products, academia and government roles.
This Graduate Certificate qualification produces career ready employable graduates.