RegulatoryAffairsSpecialist/SeniorSpecialist

**Job Description Summary** At Sandoz, our Purpose is pioneering access for patients **Job Description** We are looking for a new regulatory colleague for our life cycle management (LCM) team at Sandoz Nordic. Here, you will be responsible of our marketing authorisations (approved via National, MRP/DCP or CP), and thus responsible for affiliate life cycle activities, of a defined portfolio. You are given the opportunity to deep dive into the products and become a specialist and business partner responsible for your assigned products. Especially the latter is important, to secure products to the marked. You will be working in close collaboration across the organization, and in particular with Supply Chain/Planning, Global RA, QA/QC as well as support to the Commercial teams. This will give you a unique insight to the business and various workflows. Being a Nordic affiliate, the role is with responsibility of 5 countries, which bring many synergies but also complexity. Therefore, it is essential to have an excellent understanding of both the Nordic- and European legislation and have the ability to interpret and apply regulations appropriately. We expect from you, that you are a self-confident team player, but also able to work independently to plan, structure and coordinate your tasks within given timelines with an appropriate sense of urgency without undermining quality. You are self-motivating and thrive in a fast-paced environment. You are a fast learner and can handle multiple tasks at the same time. Furthermore, you demonstrate excellent communication skills – written and verbally. Preferably, you have good flair of IT systems and in general, a good understanding of technical IT tools. **Your Key Responsibilities:** Your responsibilities include, but not limited to: * Responsible for all life cycle management activities for own defined portfolio * Regulatory compliance of marketing authorizations. Quality (CMC) documentation and safety updates/text management, pr