Amgen Senior Regulatory Manager - EU Oncology in Uxbridge, United Kingdom
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
SENIOR REGULATORY AFFAIRS MANAGER – EU ONCOLOGY
What you will do
In 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 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.
Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
Lead development of regional regulatory documents and meetings in accordance with GRT strategy
Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
Be part of our team
You would be joining the European Oncology Regulatory team, part of the Global Regulatory Affairs function in Europe. Your colleagues are 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.
What we expect of you
We 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 discipline
Extensive experience in regional regulatory environment
Proven track record of developing and executing regional regulatory strategy
In-depth understanding of the drug life cycle and development process from a regulatory perspective
In-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 environment
Proactive approach to problem solving
Ability to understand and communicate scientific/clinical information
Ability to anticipate regulatory agency expectations
Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
What you can expect of us
As 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.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
LOCATION: Uxbridge or Cambridge with flexibility to work from home
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.