We are looking for a motivated and passionate Regulatory Manager to join our Regulatory, Quality and Compliance team to deliver a superior client experience and optimise project outcomes. This is a permanent full-time position, reporting to the Head of Regulatory, Quality and Compliance and you will support the delivery of a variety of projects, relating to pharmaceuticals, biologicals and medical devices in Australia and New Zealand.
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.

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 is Great Place to Work certified.

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.
• Performance manage and actively develop direct reports.
• 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.

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