European Regulatory Affairs Lead

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 ensure Amgen obtains and maintains the regulatory licenses required to support clinical development and commercialization of medicinal products. You will represent the region in shaping regulatory strategy, providing regional expertise, and collaborating with stakeholders to ensure regional requirements are effectively incorporated into global plans.

• →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

You would be joining the European General Medicine 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 in the Metabolic, Cardiology, Inflamation, Endocrine and Bone disease areas, as well as pre-approval filing activities for Biosimilars.

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

Objects in your future are closer than they appear. Join 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

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.