Regulatory affairs research for a medical food product

Location: Melbourne, VIC

Duration: 3-4 months

Note: there may be some flexibility in the arrangement for those residing in a state outside Victoria. Please contact Rachel Geddes for more information. 

Skills required

The successful candidate will have:

  • Strong writing skills (technical and non-technical)
  • Ability to undertake independent exploratory research
  • Prior knowledge/understanding of the international regulatory environment for pharmaceuticals
  • Ability to work as part of a wider team
  • Desirable: Knowledge in cognitive issue

Project Background

Grünbiotics is an innovative Australian life science company and an aspiring leader in the field of Medical Nutrition.

Through collaboration with top-tier pharmaceutical companies and research
institutes, Grünbiotics develops new innovative products that target nutritional deficiencies and metabolic imbalances associated with specific medical disorders and their related treatments.

Grünbiotics raised $2 million in investment in February 2016, and has since been the recipient of a Commonwealth government grant for our next product – Neurothrive, a medical food for dementia: Media Release

Based in Collins Street, Melbourne, Grünbiotics is seeking an intern to assist with the more technical and research-based aspects – the science – behind the development and launch of a pipeline of products for Australian and overseas sales.

The intern will be fully supported, and work as part of a team that includes marketing, innovation, legal, science, and manufacturing specialists. We are seeking the intern’s “pharmaceutical/bioscience/science” lens to apply to other areas of the organisation.

Research to be conducted

Grünbiotics requires help to understand and prepare the documentation required to get listing in a number of European jurisdictions, including but not limited to Europe and Asia. In some jurisdictions, the product would be classified as a New Chemical Entity (NCE), while others not. With the launch in any new market comes the requirement to provide evidence of the body of research. The research will explore:

  1. An understanding of the various requirements of the various jurisdictions.
  2. What studies/documentation do we have that supports listing in each of the jurisdictions?
  3. What is missing – what else might we need?
  4. Is there an alternative classification that we could use to enter the market? For example, as a supplement instead of a pharmaceutical? As a food rather than a supplement?

Expected Outcomes

Grünbiotics has prepared an extensive summary of the literature. They are seeking:

  1. Assistance to refine and extend this literature, including identifying the best papers and institutions to reference, from the ones they already have.
  2. Assistance to explain the ‘mechanism of action’ of their products, in lay terms. There are both commonalities, and differences; in the way their product assists people who have different cognitive issues, in particular, Alzheimer’s Dementia and depression. The explanation needs to be simple and accurate, but compelling.
  3. Assistance to understand and prepare a narrative around the science and efficacy of their products for their various target groups. These include doctors, specialists in the field, such as, gerontologist, pharmacists, investors and consumers, including carers. Some of this work is already underway.

NB:

  1. Grünbiotics is not asking for assistance to write marketing documents, rather the intern will simply to help the company understand and prepare the research/science basis for their documentation. A copywriter would be engaged to prepare the final documentation.
  2. Much of the research is on hand, although this research may need to add to the body of knowledge currently available.

Additional details

The intern will receive $3,000 per month of the internship, usually in the form of stipend payments.

It is expected that the intern will primarily undertake this research project during regular business hours, spending at least 70% of their time on-site with the industry partner. The intern will be expected to maintain contact with their academic mentor throughout the internship either through face-to-face or phone meetings as appropriate.

The intern and their academic mentor will have the opportunity to negotiate the project’s scope, milestones and timeline during the project planning stage.

To participate in the AMSI Intern program, all applicants must satisfy the following criteria:

  • Be a PhD student currently enrolled at an AMSI member institution.
  • PhD candidature must be confirmed.
  • Applicants must have the written approval of their Principal Supervisor to undertake the internship. This approval must be submitted at the time of application.
  • Internships are also subject to any requirements stipulated by the student’s and the academic mentor’s university.
Applications Close

16 August 2017

Reference:
INT – 0332