EU Regulatory Affairs Manager

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.

In this vital role you will work to ensure that Amgen acquires and maintains all the required EU licenses in order to support clinical trials for investigational medicinal products as well as marketed medicinal products.

You will support one or more products from an EU regulatory perspective.

• Depending on business needs and experience, the role may include EU Regulatory Lead responsibility for one or more products.

• 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 EU regional regulatory requirements.

• Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with EU regional legislation and regulatory requirements. Provide content guidance for regional regulatory documents and meetings in accordance with global strategy.

• Provide regulatory guidance on regional regulatory mechanisms to optimize product development ( e.g. expediting FIH studies, scientific advice, Orphan Drug, MA approval mechanisms and paediatric plans).

• Support EU label negotiation activities.

• Under general supervision participate in the development and execution of regional regulatory product strategies.

• Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.

• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.

• Perform regulatory research to obtain relevant histories,precedence and other information relevant to regional product advancement.

• Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling.

We are currently looking for x3 EU Regulatory Affairs Managers between Portugal and the United Kingdom, joining the EU Oncology or General Medicine teams, part of the Global Regulatory Affairs function in Europe.

You will 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.

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 and previous experience in a similar role.

• Hands-on experience with registration procedures in the region, such as clinical trials, pre-MAA regulatory procedures ( eg scientific advice, orphan applications or Pediatric Investigation Plans (PIPs)), MA, post-approval changes, extensions and renewals.

• Experience developing regulatory strategies for products in clinical development and post-marketing phases.

• Knowledge of EU legislation and regulations relating to medicinal products.

• Working with policies, procedures and SOP’s.

• Strong communication skills - both oral and written.

• Ability to anticipate and prevent potential issues.

• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

• Basic proficiency in using AI tools to support day-to-day work.

As we work to develop treatments that take care of others, 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…