Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. REGULATORY AFFAIRS SENIOR MANAGER - UK AND IRELANDWhat you will do Let's do this. In this vital role, you will lead regulatory activities across the UK and Ireland, ensuring Amgen obtains and maintains the necessary approvals to support clinical development and commercialization of medicinal products. You will shape UK regulatory strategies, influence global plans, and oversee local post-approval activities in Ireland, ensuring alignment with regulatory requirements and business objectives. Lead the development and execution of UK regulatory strategies, including risk assessment, contingency planning, and regulatory pathways. Plan and manage regulatory submissions, including clinical trial and marketing applications, in compliance with local requirements and global strategies. Provide strategic regulatory guidance to optimize product development and lifecycle management. Oversee post-approval regulatory activities in Ireland for Centrally Authorised products, ensuring local compliance. Lead the preparation of regulatory documentation and interactions with Health Authorities, ensuring effective communication and follow-up. Collaborate with global and cross-functional stakeholders to integrate UK and Ireland regulatory requirements into product strategies. Be part of our team You would be joining the UK and Ireland Regulatory team. You would be working with colleagues who are responsible for leading the UK 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 development assets, established products and Biosimilars. Degree educated in a scientific disciplineExtensive experience in UK regulatory environmentProven track record of developing and executing UK regulatory strategyIn-depth understanding of the drug life cycle and development process from a regulatory perspectiveIn-depth understanding of the registration procedures in the UK for MA, post approval changes, extensions and renewals including the various regulatory routes. 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 developmentWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation. .United Kingdom - Remote; Full time
Senior Regulatory Affairs Manager - Remote in London employer: Amgen
At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and growth of our employees. As an EU Regulatory Affairs Manager, you will be part of a diverse and inclusive team dedicated to serving patients, with ample opportunities for professional development and a generous Total Rewards Plan. With flexible working arrangements from our offices in Cambridge, Uxbridge, or Lisbon, you can enjoy a fulfilling career while maintaining a healthy work-life balance.
