EU Regulatory Lead Director

For the expansion of our regulatory team, argenx is looking for an EU Regulatory Lead Director, to support the rapid growth needed for successful commercialization. The role will report into the Head of Regulatory Affairs for Europe and New Territories. This role with cover primarily the EU and will require involvement in the other territories (e.g. UK, Switzerland, Israel and the Middle East...etc.).The EU Regulatory Lead Director, is a key member of the global regulatory team. This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization. In close collaboration with other functions and the broader regulatory team, this role is responsible for high quality and timely guidance in all areas of the business, from pre-approval activities, to filing, and post-approval regulatory activities, among others.Roles and Responsibilities:Provide strategic, operational and tactical regulatory insight on pre-approval and post-approval activitiesHelp guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings with EMA / applicable agencies of the EMEA regionOversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulatorsWorking with the rest of the argenx regulatory team, provide hands-on contributions to regulatory filings, and other areas as requestedProvide regulatory leadership with post-approval activitiesMonitor, interpret, and communicate changes to the global regulatory landscapeServe as the regulatory affairs business partner to local commercialization teamsPartner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisionsServe as the conduit between strategy within the assigned project team and the broader global regulatory and development teamsSkills and Competencies:Affinity with science and ability to interact with scientists and cliniciansAbility to speak and interact with a diverse group of individuals on technical and business topicsFamiliarity with current and emerging regulatory legislation, industry trends, and health care business practices globallyHighly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritizationA clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skillsYou excel in a fast-paced, results-driven, highly accountable environmentYou are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it doneYou show strong leadership with proven ability to build, motivate and develop a teamYou resonate with the values of argenx and you are ready to embrace the Company CultureYou combine strategic thinking with the ability to execute, both individually and by leading teams (in a matrix environment) to achieve operational excellence in the face of challenging goalsEducation, Experience and Qualifications:Minimum 10 years’ experience in regulatory affairs within pharmaceutical organizations, with a strong emphasis on EMA regulatory frameworks. Must include at least one end-to-end regulatory submission process, preferably with the centralized procedureAdvanced degree required; PhD or PharmD strongly preferredPrior experience working in rapidly growing pharmaceutical organizations is advantageousA thorough understanding of the drug development lifecycle with demonstrated expertise in orphan drug development, along with knowledge of the evolving global regulatory landscape, particularly across Europe and other territories (e.g. Switzerland, UK...etc.)Demonstrated ability to lead and coordinate the development of critical regulatory documents essential for the approval and life cycle management of medicinal products, with a focus on EU regulatory strategy, including Pediatric Investigation Plans (PIPs) and other key submission componentsEstablished track record of successful engagement with regulatory and health authorities, including preparation for and participation in regulatory interactions.