EU Regulatory Affairs Senior Manager (Biosimilars)

Job description

Career Category Regulatory Job Description: 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. EU REGULATORY AFFAIRS SENIOR MANAGER - BIOSIMILARS LIVE: What you will do: In this vital role you will work to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of European regulatory strategies, submissions, and plans. 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 for products within Amgen's biosimilar portfolio in compliance with global filing plans and...