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Regulatory Health Solutions Associate
3 weeks ago
The role of a Healthcare Solutions Associate is to enable the ongoing registration of life-changing healthcare solutions for patients in Australia and New Zealand.
This includes leading submissions and activities that maintain our Licence to Operate. The role supports compliance within the Regulatory Strategic Partners Chapter and ensures that supporting processes facilitate continual compliance and risk mitigation.
As a key member of the team, you will provide a deep knowledge of regulatory operational compliance in the context of our broad product portfolio.
You are driven by the purpose of improving the healthcare ecosystem, both locally and for Roche more broadly.
Key Responsibilities:
- Prepare, submit, and manage the approval process of designated regulatory applications to the TGA and Medsafe.
- Develop and implement optimised regulatory strategies to ensure products remain registered and labels are optimised throughout the lifecycle of the medicine or technology.
- Develop expertise in local operational processes and systems associated with product information, artwork, planned, and ongoing registration activities.
- Collaborate with Regulatory Affairs Partners and other cross-functional stakeholders to ensure the entire product portfolio remains fully compliant with external and internal requirements.
- Work with internal stakeholders to develop and optimise new and existing internal processes and systems.
- Provide regulatory input into pre-market, post-market, and business activities as required.
- Assist with internal and external audits and support records management.
Who You Are:
- Tertiary qualification in a life sciences field.
- 2 or more years' previous experience in a regulatory affairs or compliance role in the pharmaceutical, biotechnology, or related industry, within the Australian, New Zealand, or other relevant markets.
- A foundational understanding of the Australian and New Zealand Pharmaceutical regulatory environments.
- A strong aptitude and genuine interest in learning, using, and coaching others on complex systems.
- Advanced knowledge of Microsoft Office suite: Word, Excel, PowerPoint, and Google suite.
- Knowledge of the potential utility of AI and a continuous learning mindset.
- Very good attention-to-detail, interpersonal, communication, analytical, and problem-solving skills.
- Good organisational and time management skills.
This role is only open to candidates who have full eligibility to live and work in Australia.
We strive for excellence and extraordinary results while taking a genuine interest in our people's well-being and professional growth.
Our work gives people more time to be with the ones they love, developing diagnostics and treatments for various diseases.
We care about you - as a whole person. That's why we place your individual health and professional growth at the very heart of what we do.
We welcome applications from all people and encourage you to advise of any individual circumstances or workplace adjustments that may require consideration.
Our Team:
A healthier future drives us to innovate. Together, over 100,000 employees across the globe are dedicated to advancing science and ensuring everyone has access to healthcare today and for generations to come.
Our efforts result in millions of people being treated with our medicines and billions of tests conducted using our Diagnostics products.
Let's build a healthier future, together.
