EU Regulatory Affairs Senior Manager - General Medicine

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.

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 Regulatory team, part of the Global Regulatory Affairs function in Europe. You would be working with colleagues who 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. This team is leading the regulatory activities for established products and also development assets.

What we expect of you

• 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.

• Growth 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.

Equal Opportunity Statement

Amgen 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 essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.