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Quality & Compliance Associate

We are looking for a passionate Associate to join our Regulatory, Quality and Compliance team and to contribute to the consulting practice. This role is responsible for the preparation and submission of a range of quality and compliance documents and regulatory applications in the Japan and Asia Pacific region.

Commercial Eyes is Australia’s leading pharmaceutical and medical device commercialisation company. With a team of over 100 staff and 22 years of experience, more than 800 pharmaceutical, medical device, diagnostic, and consumer healthcare companies rely on our expertise and insights. 

In 2024, Commercial Eyes has become a part of ProductLife Group. This partnership unlocks numerous synergistic opportunities for both organisations and their clients. ProductLife Group’s global presence and expertise, combined with the regional knowledge and capabilities of Commercial Eyes, will enable ProductLife Group to deliver enhanced services and solutions to its clients. 

We are changing the way people work in one of the most regulated and complex industry in the world. Creating a collective success story for our people, our life science partners, and their patients.

Our culture of ownership and transparency empowers our team to achieve goals they did not think possible. For all those on board, it is a challenging and rewarding journey. We are innovative, fast learners, and experts in our field.

Our services are improving health outcomes and making a real difference in people’s lives. By joining our team, you are joining us in our mission to help our clients deliver a healthier tomorrow for Australia and beyond. We share a vision with our clients to make an impact on the future of human health. And we partner with them to transform therapeutic innovation into market realities for patients and healthcare, in Australia and beyond. 

The Opportunity

We are looking for a passionate Associate to join our Regulatory, Quality and Compliance team and to contribute to the consulting practice. This role is responsible for the preparation and submission of a range of quality and compliance documents and regulatory applications in the Japan and Asia Pacific region. 

This is a permanent full-time position, reporting to the Senior Manager where you will support the delivery of a variety of quality and compliance projects, relating to pharmaceuticals, biologicals and medical devices. This will include support with the management of product quality complaints, preparation and review of quality management system documentation, providing ad-hoc quality advice to clients, preparing TGA GMP clearance applications, supply chain support including reviewing imported products for supply and internal/external audit support. 

Our head office is based in the heart of Melbourne’s CBD, where we operate from a collaborative workspace. We operate under a hybrid model and offer flexibility in accordance with our company’s flexible work policy.

Some key responsibilities include:

  • Prepare, review, and update quality documentation to ensure accuracy and compliance and support audit requests and participate in audit processes as required.
  • Conduct compliance activities to align with company’s and client Quality objectives.
  • Maintain and update internal compliance templates and procedures.
  • Support senior team members with regulatory, quality, and compliance activities for clients.
  • Aid in project and client management as needed.
  • Contribute to the development of proposals for new projects and services.
  • Foster client relationships to drive client satisfaction and loyalty leading to optimisation of services across the Regulatory, Quality & Compliance service offering.

The Team

Our highly experienced Regulatory, Quality and Compliance team have in-depth knowledge of the complexity of the regulatory environment in the region. We assist our clients with the development of effective submission strategies, helping them to navigate the complex regulatory and GMP environment.

When you become part of our team, you’ll immediately feel welcomed, supported, and appreciated. Our unique and challenging consulting environment fosters a strong sense of collaboration, and it is second to none, even when working remotely.


At Commercial Eyes we:

  • Thrive on providing creative solutions to complex problems.
  • Love being exposed to diverse projects.
  • Feel comfortable with ambiguity and see it as an opportunity to generate insights.
  • Enjoy hands-on work as well as being the subject matter expert.
  • Feel inspired to deliver work that makes a difference to people’s lives through health.
  • Work flexibly and adapt quickly to changing priorities. 
    About you

    This is a fantastic opportunity for a professional with around two years of experience in a quality and compliance environment. You have a proven track record of handling confidential information and working efficiently to meet deadlines. Your attention to detail is exceptional, and you possess excellent written and spoken communication skills. You thrive in a consulting environment, eager to learn and grow while sharing your expertise in the life-science space. As an important member of our team, you will manage regulatory submissions, support audit processes, and provide high-quality guidance to our clients, ensuring their compliance and regulatory success.

     

    Desired qualifications and experience
    • Bachelor’s degree in science, pharmacy or a related discipline.
    • Minimum of 2 years’ experience in a quality and compliance environment, preferably in a commercial setting.
    • Elementary knowledge of TGA and Medsafe legislation, regulations, guidelines, and operational procedures is preferable.
    • Excellent proficiency in Microsoft Office suite, including Excel for data analysis and reporting, Word for document preparation and editing, and PowerPoint for creating presentations to support compliance and quality activities.
    • Demonstrated problem-solving abilities.

      The Rewards…

      • A collaborative culture in a growing and sustainable business  
        • At Commercial Eyes you are not just a number, you become a member of a team who supports and cares for each other. Everyone gets to know each other by name regardless of where you work from.
        • Our team is multicultural and diverse, so you will get to work with a variety of people from different ethnicities, backgrounds and with a broad range of experiences.
        • We are committed to supporting the community in which we work. The projects we support are both sustainable and recurrent including organisations such as Yalari, Purple House, Leukemia Foundation, Rare Cancers Australia and more.
      • Health and Wellbeing Program: our people get access to our EnergEyes Program, which includes an annual wellbeing allowance you can use to support your health and wellbeing including but not limited to gym memberships, fitness clothing/equipment, yoga and massage/physio sessions.
      • Paid Wellbeing Day in April to focus on your physical/mental health and general wellbeing.
      • Birthday Reward Program: An additional day of paid leave just for your birthday.
      • Career development and growth: when you join Commercial Eyes, the professional development and career opportunities are endless. If you are flexible and adaptable, you can take your career as far as you desire.

      Continue the conversation 

      If you think this role might be for you and joining the Commercial Eyes team gets you excited, please submit your application as soon as possible. We will start the shortlisting process right away.

      If you are shortlisted for this role, this is what you can expect throughout the process: 

      • Phone screening interview.
      • Interview with a member of the People & Learning team and the Reporting Manager.
      • Case study/task.
      • Psychometrics test.
      • Reference checks.

        Please note:

        • Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.
        • Commercial Eyes does not accept applications from recruitment agencies.

          If you would like more information about the role,  email our People & Learning department at [email protected]