RegulatoryAffairsManager

## **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. **REGULATORY AFFAIRS MANAGER** **LIVE** **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. You will support one or more products from a regional regulatory perspective. Strategy and Execution * 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. * Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national 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, Orphan Drug, Fast Track, compassionate use and paediatric plans) * Support regional 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 Regulatory Research * Maintain an awareness of new and developing legislation, regula