EU Regulatory Affairs Senior Manager Oncology

Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATIONIf you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.SENIOR REGULATORY AFFAIRS MANAGERLIVEWhat you will doIn this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.Representing the EU region you will be responsible for advising the GRT on regional considerations in developing strategy and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.Develop and execute regional regulatory product strategies including precedence risk management and contingency planningPlan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgens portfolio in compliance with global filing plans and local regulatory requirementsImplement product related regulatory strategies Regulatory Affairs processes and activity planningLead development of regional regulatory documents and meetings in accordance with GRT strategyProvide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies Orphan Drug Fast Track compassionate use and paediatric plan)Consistent with GRT strategy advise on regulatory implications and requirements related to global clinical development plans and objectivesLead Health Authority and Agency Interactions and document and communicate outcomes appropriatelyBe part of our teamYou would be joining the European Regulatory team part of the Global Regulatory Affairs function in Europe. You would be responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation and throughout the products lifecycle.This team is leading the regulatory activities for established products and also development assets.WINWhat we expect of youWe are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:Degree educated in a scientific disciplineExtensive experience in regional regulatory environmentProven track record of developing and executing regional regulatory strategyIn-depth understanding of the drug life cycle and development process from a regulatory perspectiveIn-depth understanding of the registration procedures in region for MA post approval changes extensions and renewals.Ability to lead teams and work collaboratively in a dynamic environmentProactive approach to problem solvingAbility to understand and communicate scientific/clinical informationAbility to anticipate regulatory agency expectationsStrong awareness of the needs of internal and external stakeholders and the role of Regulatory Affairs in driving successful drug developmentTHRIVEWhat you can expect of usAs we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being.Growth opportunities to learn and move up and across our global organizationDiverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health finance and wealth work/life balance and career benefitsLOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.The position can also be located in our Lisbon office.APPLY NOWfor a career that defies imaginationIn our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. Join us.Amgen is an Equal Opportunity employer and will consider you without regard to your race colour religion sex sexual orientation gender identity national origin protected veteran status or disability status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation..Required Experience:Senior Manager Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1