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. 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 industry 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.We are elevating and refining the commercialisation process for human therapeutics – introducing smart processes and new technologies to work smarter, not harder.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."Working at CEPL has provided me with the opportunity to advance my career, pursuing my commitment to develop innovations in healthcare. CEPL promotes and supports professional growth together with personal health and wellbeing through its stimulating, flexible and diverse working environment." – Sarah Anderson, Associate – Regulatory, Quality & ComplianceThe OpportunityWe are looking for a motivated and passionate Associate Consultant 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 Senior Manager and you will support the delivery of a variety of projects, relating to pharmaceuticals, biologicals and medical devices in Australia and New Zealand.This role contributes to our consulting practice by preparing and submitting regulatory applications, compliance documents, and supporting various projects for clients in Australia and New Zealand.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 policySome key responsibilities include:Provide support and assistance to clients for the registration and listing of pharmaceuticals, biologicals, and medical devices in Australia and New Zealand.Assist with 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.Develop subject matter expertise and mentor junior staff, fostering professional growth.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 summariesThe TeamOur highly experienced Regulatory, Quality and Compliance team have in-depth knowledge of the complexity of the regulatory environment in Australia and New Zealand. We assist our clients with the development of effective submission strategies, helping them to navigate the complex regulatory environment in Australia, New Zealand (and beyond) and navigating through 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:About you This role is ideal for a highly independent and proactive individual who thrives on taking ownership of projects and managing multiple clients simultaneously. You possesses exceptional problem-solving and project management skills, demonstrating a strong ability to navigate challenges and deliver results with accountability. You are adept at meeting deadlines while maintaining meticulous attention to detail in all aspects of their work. With outstanding written, spoken, and interpersonal skills, you can effectively communicate and collaborates with internal teams and clients alike, setting a standard of excellence in all interactions.Desired qualifications and experience Have completed studies in pharmaceutical sciences or related scientific field.Minimum 4 (four) years of experience in Australian and New Zealand quality or regulatory affairs, preferably in a commercial setting.Strong understanding of TGA and Medsafe regulations, guidelines, and working procedures.Proficient computer skills with a commitment to confidentiality.Previous experience in project management and/or consulting is preferred, demonstrating an ability to effectively navigate complex projects and collaborate with diverse stakeholders.Excellent communication skills, attention to detail, and a passion for continuous learning."Managing such a wonderful team at Commercial Eyes 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 & ComplianceThe 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.Our team is multicultural and diverse, so you will get to work with a variety of people from different ethnicities, backgrounds and with a broad range of experiences.We are committed to supporting the community in which we work. The projects we support are both sustainable and recurrent including organisations such as Yalari, Purple House, Leukemia Foundation, Rare Cancers Australia and more.Health and Wellbeing Program: our people get access to our EnergEyes Program, which includes an annual wellbeing allowance you can use to support your health and wellbeing including but not limited to gym memberships, fitness clothing/equipment, yoga and massage/physio sessions.Paid Wellbeing Day in April to focus on your physical/mental health and general wellbeing.Birthday Reward Program: An additional day of paid leave just for your birthday.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.#J-18808-Ljbffr
