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 and 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 industries 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.
"One of the things I love the most about working at CEPL is the flexibility. I have members of my team working from around the world. As long as we have some working hours that overlap, everyone can work when and where they want"–Maria – Head of Regulatory, Quality & Compliance
The Opportunity We are excited to welcome an enthusiastic Senior Consultant to our team on a full-time basis. In this dynamic role, you will be a key player within our Regulatory, Quality & Compliance team, delivering a wide range of regulatory applications across the Japan and Asia Pacific region.
As a Senior Consultant, you will manage client projects, collaborating closely with team members to ensure an exceptional client experience, optimise project outcomes, and enhance our team's culture and capabilities. This position reports to the Senior Manager, Regulatory, Quality, and Compliance. If you are eager to make a significant impact and thrive in a dynamic environment, this is a position for you!
Key responsibilities include:
Act as a subject matter expert and provide support and assistance to clients regarding type and quality of clinical and non-clinical, chemistry, manufacturing, and controls (CMC) 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 documentation. Ensure quality control of applications, regulatory, quality, and compliance documents.
Assist clients in responding to regulatory agency questions and with maintaining current registrations, listings, and inclusions.
Develop strong relationships with existing clients, providing high-quality consulting services to enhance client satisfaction and loyalty.
Build strong networks within the life sciences sector to identify potential business opportunities and act as a brand ambassador.
Proactively identify business development opportunities and work with existing and potential clients to understand their needs.
Act as Project Manager, providing leadership through client liaison, project scoping and proposal development, team resourcing, project management, delivery, and client follow-up.
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 great opportunity for a skilled regulatory professional with an extensive background in the pharmaceutical or life-science space. If you are passionate about consulting and eager to broaden your expertise across a diverse range of products and therapeutic areas—including prescription and over-the-counter (OTC) medicines, complementary medicines, sunscreens, medical devices, and cosmetics—this role is an ideal fit for you.
You are a dynamic individual with a proactive and independent approach to problem-solving. You should possess high-level written and oral communication skills, enabling you to articulate complex regulatory concepts clearly and effectively. Your proven problem-solving abilities and strong project management skills will be crucial in navigating regulatory challenges and delivering successful project outcomes.
In addition to your technical expertise, we value leadership and mentorship skills. Experience or a strong aptitude for guiding and developing team members would be welcomed as they would play a key role in fostering a collaborative and high-performing team environment.
Desired qualifications and experience Bachelor's degree in science, pharmacy or other scientific discipline.
Minimum 8 (eight) years of experience in regulatory affairs, preferably in a commercial setting.
Strong understanding of TGA and Medsafe regulations, guidelines, and working procedures.
Experience in technical/medical writing, particularly associated with therapeutic product requirements.
Experience in the review, critical evaluation and presentation of clinical and non-clinical data.
Regulatory experience in jurisdictions outside of Australia and New Zealand is desirable.
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.
Health and Well-being Program: our people get access to our EnergEyes Program, which includes an annual Well-being allowance you can use to support your health and well-being including but not limited to gym memberships, fitness clothing/equipment, yoga, and massage/physio sessions.
Paid Well-being Day: to focus on your physical/mental health and general well-being.
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.
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 conversation.
Interview with a member of the People & Learning team and the Reporting Manager.
Case study/task.
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.
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