Senior Regulatory Consultant

Job Description

Commercial Eyes (CE) is Australia’s leading pharmaceutical and medical device commercialisation company. With a team of over 100 staff and 23 years of experience, over 900 pharmaceutical, medical device, diagnostic, and consumer healthcare companies rely on our expertise and insights. As part of ProductLife Group, our local and regional expertise and insights, coupled with PLG’s global presence and knowledge, enable us to deliver tailored, high-quality solutions to our clients locally and globally. The Opportunity The Senior Consultant manages client projects, working closely with other team members to deliver a superior client experience, optimise project outcomes, and contribute to the culture and capabilities of the team. This permanent, full-time position reports to the Manager and works within the Regulatory, Quality & Compliance team to deliver a range of product development projects and regulatory applications in Australia, New Zealand and Japan and Asia Pacific (JAPAC) region. The role acts as Project Manager, providing project leadership, including client liaison, project scoping and proposal development, project team resourcing, project management and delivery, and client follow-up. The role contributes to the BU’s business growth efforts by proactively identifying business development opportunities and working with existing and potential clients in the healthcare sector to anticipate and understand their business needs and identify areas or activities with which CE can assist. Some key responsibilities include: Fostering relationships and collaborating with other business units to support cross-collaboration within the business, drive innovation, create efficiencies, and expand service offerings across the business. Providing high-quality work that contributes to client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering. Supervising and mentoring other members of the project team as required. Delivering strategically and technically sound project outcomes, regulatory submissions, reports, and presentations according to agreed deadlines and client requirements. 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 development, 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 CE, 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 in people’s lives through health. Work flexibly and adapt quickly to changing priorities. About you This role is a fantastic opportunity for an experienced regulatory professional with expertise in the Australian, New Zealand, and/or JAPAC regulatory landscapes. You bring a proven track record in regulatory roles and have a passion for both learning and sharing your knowledge of the pharmaceutical or healthcare industry. Strong project and people management skills and exceptional communication abilities are key to succeeding in 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. 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, nonclinical and quality data. Proven problem-solving and project management skills. Proven experience in people supervision, mentoring and leadership. Post-graduate qualifications in a relevant discipline are preferable. 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 a diverse group of people from various backgrounds and experiences. 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, professional development and career opportunities are limitless. Commercial Eyes is Great Place to Work certified. Continue the conversation 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 conversation. Interview with a People & Learning team member and the Reporting Manager. Case study/task. Reference checks. Please note: At Commercial Eyes, we value diversity and inclusion and consider all candidates equally. Commercial Eyes does not accept applications from recruitment agencies. #J-18808-Ljbffr