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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.
Job Responsibility
Responsible for all life cycle management activities for own defined portfolio
Regulatory compliance of marketing authorizations
Quality (CMC) documentation and safety updates/text management, prepare and ensure timely submission for products in the Nordics
Respond to requests from the health authorities as well as being responsible for providing approved texts for implementation in due time
Close collaboration with Supply Chain/Planning/QA/QC and commercial teams as well as Global RA with focus on business partnership
Act as an expert, ensuring compliance with regulatory guidelines, provide guidance on national and EU legislation within the regulatory field
Regulatory handling of change controls and deviations in GxP validated IT System
Requirements
University degree on relevant field e.g pharmaceutical or life sciences
Preferably 1-5 years of experience from a position in regulatory affairs, but with the right personal competences a newly graduated could also be a match
Proactive, a team player, systematic and can establish and discuss a regulatory approach including risks and benefits for life-cycle management activities
Strong communication skills, written and verbally
Mother tongue in either Danish, Swedish or Norwegian and English both verbal and written
Technical flair – e.g. experience/interest in working with (EDMS) Electronic Document Management System, (RIMS) Regulatory Information management System or the like.
Nice to have
Good flair of IT systems
A good understanding of technical IT tools
What we offer
Competitive salary and Bonus based on personal and company results
Pension Scheme
Health Insurance
Flexible working conditions with hybrid working policy