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Regulatory & Pharmacovigilance (PV) Senior ManagerAustralia & NZ Full-timeAbout The PositionAt Medison, we are a purpose-driven, global biotech company committed to bringing life-changing therapies to people living with rare and severe diseases. We believe that access to the best available treatments should not be limited by geography - and we are here to make that belief a reality.As we continue to expand across international markets, were building a world-class team in Australia and New Zealand - and were looking for an experienced Regulatory & Pharmacovigilance (PV) Senior Manager to lead these critical functions in the region.Why Join Us?Make real impact: Play a pivotal role in bringing rare disease and oncology therapies to patients who need them most.Shape the future: Be part of a fast-growing, agile company where your voice and expertise influence decisions.Grow with us: Thrive in a high-trust, high-performance culture that values curiosity, collaboration, and innovation.ResponsibilitiesAs the Regulatory & PV Senior Manager, ANZ, youll lead both the strategic and operational execution of all regulatory affairs and pharmacovigilance activities across Australia and New Zealand.What Youll Do:Regulatory Affairs (RA)Develop and lead local RA strategies to support TGA and Medsafe submissions.Maintain up-to-date knowledge of regulatory changes across ANZ, advising both local and global stakeholders.Drive end-to-end submission processes, including PI and CMI updates, promotional material review, and local compliance.Lead vendor selection and oversight where third-party RA support is needed.Provide strategic input on pipeline products and new opportunities.Pharmacovigilance (PV)Serve as local Qualified Person for Pharmacovigilance (QPPV) for the TGA.Build and maintain a fully compliant PV system, in line with both local and global regulations.Oversee collection, processing, and reporting of safety data to regulatory authorities.Manage local PV vendors and safety agreements (SDEAs/PVAs).Lead PV inspection readiness, internal audits, and training across the affiliate.Represent RA & PV as a member of the ANZ Management Team.Act as a key advisor on cross-functional initiatives including Market Access, Medical Affairs, and Commercial.Foster a culture of operational excellence, continuous improvement, and ethical integrity.RequirementsWhat You Bring:7+ years of Regulatory Affairs experience in prescription medicines (rare disease/biotech preferred).Proven experience managing TGA and/or Medsafe submissions.PV experience; QPPV designation or equivalent a strong advantage.Strong working knowledge of global and local PV systems, safety data, and regulatory frameworks.Experience in vendor management, auditing, and working in a matrix environment.Comfortable navigating ambiguity and lean structures in a high-growth environment.Strategic mindset with the ability to zoom in on the details when needed.Collaborative spirit and a drive to challenge the status quo with purpose.Ready to join a company where you can make a difference from Day One?Apply now and help us rewrite the future of rare disease and oncology treatment in Australia, New Zealand - and beyond.Medison is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.Always Ahead","library":"fa-solid"}}'' data-widget_type="nav-menu.default"> #J-18808-Ljbffr