AddressbWellness is a growing nutraceutical and bioregulatory medicine company that manages well-known, Practitioner-Only brands such as Bio-Practica and Brauer Professional. bWellness is dedicated to supporting the work of natural medicine practitioners with high quality education, information, and premium nutraceutical products.
Well versed in Natural medicine and the associated regulatory environment, the Research & Development Officer will be responsible for managing and maintaining the regulatory compliance of the products across the bWellness brands, as well as working with external suppliers to ensure ingredients and products are meeting requirements. The Research & Development Officer is also responsible for the research of new products, to ensure formulas meet briefs.
Role Responsibilities include
- Keep up to date with the regulatory framework for natural medicines across Australia and New Zealand
- Ensure that all current and future products, including AUST L, extemporaneous compounding and food products, meet Australian Therapeutic Goods Administration (TGA) and Food Standards Australia and New Zealand (FSANZ)
- Research, analyse and provide evidence-based formulas for new product developments (NPD) for the bWellness product range based on the strategic marketing objectives of the company.
- Coordinate and manage NPD, existing product development (EPD) and change controls on time and to brief; and oversee the stage-gated NPD process, from ideation to launch.
- regulatory requirements respectively.
- Edit and review technical writing, copywriting, education, and training materials to ensure regulatory compliance and technical accuracy
- Working closely, building and maintaining rapport with co-manufacturers, partners and regulatory consultants.
- Assist with pharmacovigilance tasks such as researching and writing safety data for ingredients and products as required, also managing and keeping quality assurance (QA) documentation up to date to be pharmacovigilance and regulatory compliant.
Qualifications and Experience
- Tertiary qualification in Health Sciences – Homeopathy, Naturopathy, Nutrition or similar
- 5 years’ experience in a similar role highly regarded
- Pay commensurate with experience.
Capabilities required
- Strong written and verbal skills with an ability to critique, interpretate and translate technical research and information
- Strong knowledge of the Regulatory framework, including TGA, ARTG, FSANZ and CMA Practitioner Only Products guidelines
- Well-developed organisation skills, including the ability to meet tight and/or competing deadlines, achieve established targets, prioritise work and multi-task when required
- Ability to use own initiative and apply sound judgement when faced with both day-to-day and more complex/sensitive problems or challenges
- Ability to work autonomously as well as an effective member of a team
- Demonstrated competence in the Microsoft suite of programs, including Word, Excel, PowerPoint, etc.
- Proven, well-developed interpersonal skills that promote trust, engagement and credibility across a broad range of customers, staff members and other key internal and external stakeholders
