Join our team atAMGEN Capability Center Portugal, number 1 company in Best WorkplacesTM ranking in Portugal in 2024 by the Great Place to Work Institute. We have a team of over 500 talented people and more than 40 nationalities, diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs and many more. In Lisbon's city center, our AMGEN office fosters innovation, excellence, and inspiration. Come thrive with us at AMGEN, supporting our mission To Serve Patients. What we do at AMGEN matters in people's lives. SENIOR ASSOCIATE REGULATORY AFFAIRSAmgen's Regional Regulatory Affairs team offers European regulatory leadership and execution across the development, registration, and lifecycle management of all Amgen molecules. The team thrives on innovation and collaborates cross-functionally to advance product strategies through regulatory authority interactions. Our team is seeking a motivated regulatory professional, inspired by Amgen's science, to support our mission of serving patients. LIVEWHAT YOU WILL DOLet's do this. Let's change the world. In this vital role you will be assigned to one or more Amgen products and may support a Regional Regulatory Lead (RRL) or lead a program under the supervision of an experienced regulatory lead. Key ResponsibilitiesExecute theEU regulatory strategyand EU regulatory plans. Prepare supportive documentation for regulatory deliverables, including the management of clinical trial applications, marketing authorizations, and lifecycle management activities. Use of Amgen systems and document management. Ensure and supportregulatory product compliance. Work with policies and SOPs. Buildeffective relationshipsandcommunication pathsacross local and functional organizations. Enableefficienciesand seamless execution across the region countries. 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, autonomous and collaborative professional, with these qualifications and skills: MINIMUM REQUIREMENTSMaster's degree or Bachelor's degree (scientific area) and 3 years of directly related experience. Demonstrated experience in clinical trial regulatory affairs. Previous experience in developing and maintaining CTA documentation in Europe (e.g. IMPDs, IMPD amendments) is ideal. Depth knowledge of EU legislation and regulations relating to medicinal products is ideal. Adaptability and strong English communication skills, both oral and written. THRIVEWHAT YOU CAN EXPECT OF USAs we work to develop treatments that take care of others, we also care deeply for our teammates' well-being and growth. Vast opportunities to learn, develop, and move up and across our global organization. Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act. Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits. Flexible work arrangements. APPLY NOWObjects in your future are closer than they appear. Join us. CAREERS.AMGEN.COM EQUAL OPPORTUNITY STATEMENTAMGEN is an Equal Opportunity employer and will consider you without regard to your race, color, 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 crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.#J-18808-Ljbffr