Home Consultant, Regulatory, Quality and Compliance

Consultant, Regulatory, Quality and Compliance

We are looking for a dedicated Consultant to join our Regulatory, Quality & Compliance team to provide strategic advice to clients regarding regulatory environment and manage the registration and listing of medicines and medical devices 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 dedicated Consultant to join our Regulatory, Quality & Compliance team to provide strategic advice to clients regarding regulatory environment and manage the registration and listing of medicines and medical devices in the Japan and Asia Pacific region. 

This is a full-time position reporting to the Manager to support the delivery of a variety of projects requiring a sound knowledge of the type and quality of evidence necessary for new medicines registrations or medical device inclusions, as well as related life cycle management activities. 

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:

  • Provide support and assistance to clients regarding type and quality of chemistry, manufacturing, and controls (CMC), clinical and non-clinical evidence to support new medicine registrations and medical device inclusions.
  • Support clients through the registration and listing process for pharmaceuticals, biologicals, and medical devices and assist with maintaining current registrations.
  • Review, critically evaluate, prepare, and submit regulatory dossiers to relevant agencies.
  • Manage clients and projects and support project teams as required.
  • Review and ensure quality and compliance of applications and documentation.
  • Assist in the preparation of literature-based submissions, including overviews and summaries.
  • Provide strategic regulatory advice to clients regarding the JAPAC regulatory environment.
  • Build and leverage strong networks across the life sciences sector to identify business opportunities for Commercial Eyes

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.

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 and navigating through various challenges during the approval and life-cycle management process.

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 unique opportunity for a skilled regulatory professional with extensive medical device experience and background in the pharmaceutical or healthcare industry. You are interested in consulting and keen to broaden your knowledge across different products and therapeutic areas, including: medical devices, prescription, over the counter (OTC) and complementary medicines, sunscreens and cosmetics.

 

Desired qualifications and experience
  • Bachelor’s degree in science, pharmacy or other scientific discipline.
  • Post-graduate qualifications in a relevant discipline, is desirable.
  • Minimum 5 (five) years of experience in regulatory affairs, including experience in medical devices , preferably in a commercial setting.
  • Strong understanding of TGA and Medsafe regulations, guidelines, and working procedures.
  • Experience in preparing literature-based submissions, including associated overviews and summaries.
  • Client management and/or consulting experience would be highly regarded.

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.
  • 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 Day Off: 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.

Visit our People & Careers page to find out more about Life at Commercial Eyes https://commercialeyes.com.au/people-and-careers/

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.
  • Reference checks.
  • Psychometrics test.

      Please note:

      • 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]