Regulatory Manager

Commercial Eyes is Australia's leading pharmaceutical and medical device commercialisation company.
With a team of over 100 staff and 23 years of experience, over 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 Commercial Eyes' regional knowledge, enable us to deliver even greater services and solutions to our clients.
The Opportunity
We are looking for a dynamic and forward-thinking Manager to join our Regulatory, Quality, and Compliance team.
The manager will be responsible for the day-to-day operational management of the assigned project portfolio and direct reports in the Regulatory, Quality and Compliance function.
This permanent, full-time position reports to the Senior Manager and is responsible for delivering the business unit's objectives, managing projects and people to ensure optimum project outcomes, and developing strategic plans to drive the business unit's development and growth.
Projects span across the range of the product lifecycle from initial product development to regulatory applications and ongoing post market support within the Japan and Asia Pacific (JAPAC) region.
The role also involves implementing and maintaining systems to improve the operational efficiency of Regulatory, Quality and Compliance project teams, managing customer relationships, and supporting new business initiatives and opportunities.
The role is accountable for supporting the development and implementation of business development initiatives, meeting agreed-upon financial and productivity objectives, ensuring teamwork, cross-functionality, and efficiencies across the business, encouraging value-based professional conduct, and delivering excellent client service.
Some key responsibilities include :
Foster relationships and collaborate with other business units to support cross-collaboration within the business, drive innovation, create efficiencies, and expand service offerings across the business.
Provide high-quality work that contributes to client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision across the RQC service offering.
Work closely with the Senior Manager on matters of strategic importance and provide relevant insights to the Consulting Leadership team.
Provide assistance and support to the Senior Manager in areas of the business unit management, including the development and implementation of strategic plans, as required.
Provide specialist knowledge, advice and guidance on best practices and develop resources to enable the delivery of high-quality Regulatory, Quality and Compliance services.
Review and QC applications, regulatory, quality and compliance documentation as required.
The Team
Our highly experienced Regulatory, Quality, and Compliance team has in-depth knowledge of the regulatory environment in the region.
We assist our clients with the development of effective submission strategies, helping them navigate the complex regulatory environment and various challenges during the approval and life-cycle management process.
We have a trusted history of success, managing over 160 projects each year, including the submission of 60 major applications to regulatory authorities.
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.
Managing such a wonderful team at CE is what I enjoy the most – our diverse range of projects and clients allows each team member to both utilise and develop their expertise and I am so proud of the excellent service we are able to provide" – Colleen, Senior Manager – Regulatory, Quality and Compliance
About you
This is an excellent opportunity for an experienced people manager and regulatory professional with expertise in Australian and New Zealand and / or JAPAC regulatory environments.
You have a strong track record working in quality and / or regulatory roles and are passionate about learning and sharing your knowledge of the pharmaceutical or healthcare industry.
In addition, project and people management expertise and excellent communication skills are essential for this role.
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.
Desired qualifications and experience
Have completed studies in pharmaceutical sciences or related scientific fields.
Post-graduate qualifications in a relevant discipline are preferable.
Proven record of consulting experience in Australian and New Zealand and / or JAPAC regulatory affairs, preferably in a commercial environment.
Comprehensive knowledge of TGA and Medsafe legislation, 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 quality data.
Financial acumen and demonstrated business development skills.
Proven experience in people supervision, mentoring and leadership.
The Rewards...
Collaborative Culture : Join a growing and sustainable business where you're not just a number but a valued team member.
Diverse Team : work with multicultural and diverse group of people from various backgrounds and experience.
Health and Wellbeing Program : Access to our EnergEyes Program, including an annual wellbeing allowance to support your health and wellbeing.
Paid Wellbeing Day : Focus on your physical and mental health with an additional paid day off.
Birthday Day Off : Enjoy an additional day of paid leave to celebrate your birthday.
Career Development : With Commercial Eyes and the ProductLife Group the professional development and career opportunities are limitless.
Commercial Eyes isGreat Place to Work certified.
Continue theconversation
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.
Please note :
Here at Commercial Eyes wevalue diversity and inclusion and consider all candidates equally.
Commercial Eyes does not accept applications from recruitment agencies.
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