EU Senior Global Reg Affairs Project Leader (m/f/d) in Sachseln

The Role & What You Will Be DoingEvery day, we rise to the challenge to make a difference and here’s how the EU Senior Global Reg Affairs Project Leader (m/f/d) role will make an impact:Define and execute EU regulatory strategies in alignment with global development plansServe as primary EU regulatory contact with EMA and coordinate interactions with National Competent AuthoritiesLead preparation and execution of Scientific Advice, regulatory meetings, and related briefing packagesOversee EU regulatory submissions including IMPDs, PIPs, Orphan Drug Applications, MAAs, variations, and life-cycle updatesEnsure EU labeling compliance and alignment with the Company Core Data SheetRepresent Regulatory Affairs on cross-functional project and governance teamsMaintain regulatory intelligence and assess impact of new guidance and regulationsContribute regulatory expertise to due diligence and business development activitiesDevelop and lead global regulatory strategies and Regulatory Functional PlansCoordinate global submission planning and executionOwn creation and maintenance of the global Company Core Data SheetLead regulatory sub-teams and ensure delivery of regulatory milestonesSupport affiliates and partners with global regulatory strategy and executionAbout Your Skills & ExperienceFor this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:Master’s degree (or equivalent) in Life Sciences or related discipline8+ years of Regulatory Affairs experience within pharma or biotechExpert knowledge of EU, ICH, and global regulatory frameworksExtensive experience working with EMA and EU National Competent AuthoritiesStrong understanding of clinical development and regulatory life-cycle activitiesExcellent communication, stakeholder management, and project leadership skillsFluent English (written and spoken)What We OfferFriendly working atmosphere in our great office premises in AllschwilHome office option up to 2 days per weekDevelopment opportunities within an international companyAt Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.Why Viatris?At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace,Diversity & Inclusion at ViatrisAt Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be.If you would like to know more about what diversity, equity and inclusion means to us, please visit Website at ViatrisCorporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve.To learn more about our efforts, please visit Website Viatris, bieten wir wettbewerbsfähige Gehälter, Sozialleistungen und ein integratives Umfeld, in dem Sie Ihre Erfahrungen, Perspektiven und Fähigkeiten einsetzen können, um das Leben anderer zu beeinfluss. Viatris ist ein globales Gesundheitsunternehmen, das 2020 durch die Fusion von Mylan und Upjohn, einem früheren Unternehmensbereich von Pfizer, entstanden ist. Durch die Verbindung der Stärken beider Unternehmen mit etwa 45.000 Beschäftigten weltweit streben wir an, den Zugang zu kostengünstigen, qualitativ hochwertigen Medikamenten für Patienten weltweit, unabhängig von ihrem Wohnort oder ihren Lebensbedingungen, zu erleichtern. Wir glauben an ein Gesundheitswesen, wie es sein sollte – damit Menschen weltweit in jeder Lebensphase gesünder leben können. Basierend auf unserer unerschütterlichen Überzeugung, dass ein verbesserter Zugang auch zu einer besseren Gesundheit führt, setzen wir unser erstklassiges wissenschaftliches Fachwissen und Produktions-Know-how sowie unsere bewährten kommerziellen Fähigkeiten optimal ein, um Patienten hochwertige Medikamente bereitzustellen, wann und wo auch immer sie diese benötigen. #J-18808-Ljbffr