Amgen European Regulatory Affairs Lead in Cambridge, United Kingdom
Regional Regulatory Affairs Lead – EU General Medicine
The Amgen Regional Regulatory General Medicine Team is looking for an experienced Regulatory Lead. As a member of the Global Regulatory Team (GRT), you will be responsible for developing and executing regional regulatory strategies and managing Regulatory Agency interactions.
If you are looking for your next career step and want to be part of our mission – To serve patients – which drives all that we do, apply or get in touch. Take a look at our career pages to find out more about Amgen UK http://careers.amgen.com/uk-ireland
Our Regional Regulatory General Medicine Team:
The European General Medicine Regulatory Therapeutic Area team are part of the Global Regulatory Affairs function in Europe and 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.
The General Medicine regulatory team are leading the regulatory activities for established products and also development assets in the Metabolic, Cardiology, Inflammation, Endocrine, Bone and Neuroscience disease areas, as well as pre-approval filing activities for Biosimilars.
Your role as a Regional Regulatory Lead:
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
Your knowledge and required experience/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 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
Ability to lead teams and work collaboratively in a dynamic environment
Excellent verbal and written communication skills
Proactive approach to problem solving
Location: Uxbridge or Cambridge
Remuneration: Competitive salary & comprehensive benefits package including bonus scheme
About our company:
Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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.