We are looking for a passionate Associate to join our Regulatory, Quality and Compliance team to deliver a superior client experience and optimise project outcomes.
Commercial Eyes is Australia's leading pharmaceutical and medical device commercialisation company.
With a team of over 100 staff and 23 years of experience, we provide trusted expertise and insights to more than 800 pharmaceutical, medical device, diagnostic, and consumer healthcare sectors.
In 2024, we proudly joined ProductLife Group, a partnership that combines ProductLife's global presence and expertise with our local knowledge and capabilities.
Together, we deliver enhanced services and solutions to clients in the life sciences industry.
The OpportunityThis is a permanent full-time position, reporting to the Manager, and you will support the delivery of a variety of client projects in Australia, New Zealand and Japan and Asia Pacific (JAPAC) region.
Key responsibilities include:Preparation and submission of regulatory dossiers to the TGA and Medsafe, ensuring accuracy and compliance.Support clients in maintaining current registrations and listings, addressing inquiries from regulatory authorities.Collaborate with senior team members on complex regulatory applications, contributing to successful submissions.Assist with project management, GMP clearance applications, quality documentation, and cross-departmental collaboration to optimise service provision and client satisfaction.Support the preparation of literature-based submissions, including the preparation of associated overviews and summaries.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 TeamOur 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.
About youThis role is perfect for an independent and proactive individual who enjoys supporting projects and contributing to our team's client management efforts.
You are adept at meeting deadlines while maintaining attention to detail in all aspects of your work.
With excellent written, spoken, and interpersonal skills, you can effectively communicate and collaborate with internal teams and clients alike, setting a standard of excellence in all interactions.
Desired qualifications and experienceHave completed studies in pharmaceutical sciences or related scientific field.Minimum 2 (two) years of experience in Australia, New Zealand and/or JAPAC region quality or regulatory affairs, preferably in a commercial setting.Basic knowledge of TGA and Medsafe regulations, guidelines, and working procedures would be advantageous.Proficient computer skills.Previous experience dealing with a high level of confidentiality.The Rewards…Collaborative Culture: Be part of a growing and sustainable business where you are a valued as a team member.Diverse Team: Work with a multicultural group of professionals from various backgrounds.Health and Wellbeing Program: Access to our EnergEyes Program, including an annual wellbeing allowance to support your health and wellbeing.Paid Wellbeing Day: Enjoy an extra day off to focus on your health and wellbeing.Birthday Day Off: Celebrate your birthday with an additional paid day off.Career Development: With Commercial Eyes and ProductLife Group, the possibilities for growth and career progression are limitless.Commercial Eyes is Great Place to Work Certified.
Continue the conversationIf 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.Case study/task.Interview with a member of the People & Learning team and the Reporting Manager.Reference checks.Psychometrics test.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.If you would like more information about the role, email our People & Learning department at
#J-18808-Ljbffr
