EU Regulatory Affairs Senior Manager - Oncology

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.

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 EU 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.

• Develop and execute regional regulatory product strategies, including precedence, risk management and contingency planning.
• 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).
• 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.

You would be joining the European Regulatory team, part of the Global Regulatory Affairs function in Europe. You would be 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.

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.

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.

LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

Join us in our quest to serve patients above all else.