Consultant, Quality and Compliance (Consulting)

at  Commercial Eyes

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, we are the only consultancy that offers full end-to-end commercialisation services. We understand local market dynamics, navigate the most appropriate regulatory and reimbursement pathway, communicate the value and benefits of product innovation, and assist sponsors to meet their post market safety requirements throughout the life cycle of products.
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.

THE OPPORTUNITY

We are looking for a skilled Consultant experienced in Quality to join our Regulatory, Quality and Compliance team and to contribute to the consulting practice. 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, within the Japan and Asia Pacific (JAPAC) region. The Consultant will manage client projects, working closely with other members of the team, to deliver a superior client experience and optimise project outcomes.

DESIRED QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree in science, pharmacy or other scientific discipline.
• Minimum of 5 (five) years’ experience in a quality and compliance environment.
• Good knowledge of legislation, regulations, guidelines and working procedures within the JAPAC region.
• 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.
• Previous consulting experience is highly preferred.

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.

SOME KEY RESPONSIBILITIES INCLUDE:

• Provide project management support, including client liaison, project scoping, proposal development, team resourcing, project management, delivery, and client follow-up and work closely with project teams to deliver strategically and technically sound project outcomes.
• Provide quality and compliance services to support the sponsorship and supply of registered or listed pharmaceuticals, biologicals, and medical devices.
• Review batch documentation and provide release recommendations.
• Manage GMP Clearance applications for submission to TGA.
• Prepare, review, critically evaluate, and approve quality documentation for clients and for submission to regulatory authorities.
• Support clients with registration, listing, and maintenance of pharmaceuticals, biologicals, and medical devices.
• Supervise, mentor, and coach team members, providing training and guidance to less experienced colleagues.

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