Head of Regulatory Affairs | New leadership role! | MEL based Skip to content Head of Regulatory Affairs | New leadership role! | MEL based Pharmaceuticals & Medical Devices (Healthcare & Medical) Full time Add expected salary to your profile for insights We are excited to be partnering with this international biopharmaceutical company dedicated to providing new and innovative therapies and technologies that fulfil unique unmet needs in our community. As leaders in the commercialisation of products across various therapeutic areas, they have established a strong reputation for successfully promoting partner products in ANZ and SEA. With a steadfast commitment to patient care and delivering value to customers, they foster a culture of innovation and entrepreneurship. Their efforts are driven by solid clinical evidence, close customer partnerships, and exceptional service.Reporting to the CEO and as a part of the leadership team your responsibilities will include:Managing the submission process and working closely with health authorities TGA and Medsafe and SEA stakeholders.Leading the review, interpretation, development and submission of technical files and regulatory dossiersProviding input on possible new ways of drug development and registration and work on proposals for business development.Managing and maintaining all regulatory registrations in accordance with the latest standardsWorking cross-functionally with marketing and sales team as part of the leadership team.Supporting, growing and developing the Regulatory Affairs team.Overseeing other related areas and functions to ensure all Adverse Events, product and/or quality complaints are appropriately addressed and processedTo be successful in this role you will have:Tertiary scientific qualification Life SciencesAn extensive track record in efficient submissions biologicals & orphan drugs.Strong strategic & executional expertise across multiple launchesExternal stakeholder managementExposure to APAC markets will be advantageousStrong presentation & relationship building skillsExcellent organisational skills & attention to detailCandidates with a background on biologicals and orphan drugs will be highly regarded. What is also important is that you enjoy working with a dynamic and mature team in a hands-on role where your experience and expertise will play a large contribution to the wider business. This is a truly exciting opportunity to make your impact in a specialty therapeutic area with a fast growing business.To apply for this role please submit your application in WORD format by clicking 'apply'; or contact Jasmine Garbino on 0460 947 804 for further queries. Confidentiality is assured. About the recruiter Your application will include the following questions: Which of the following statements best describes your right to work in Australia? Do you have a current Police Check (National Police Certificate) for employment? To help fast track investigation, please include here any other relevant details that prompted you to report this job ad as fraudulent / misleading / discriminatory. Need to upskill? Choose from thousands of courses delivered by leaders in education.
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