Regulatory Affairs Specialist
2 days ago
We are looking for a new regulatory colleague for our life cycle management (LCM) Product team at Sandoz Nordic. Here, you will be responsible for our marketing authorisations for affiliate life cycle activities, of a defined portfolio.
Here, you are given the opportunity to deep dive into the products and be the best sparring partner possible for your assigned products. Especially the latter is important, as you will be working in close collaboration across the organization, particularly with Supply Chain/Planning, Global RA, and QA/QC. This will give you a unique insight into the business and various workflows.
Being a Nordic affiliate, the role is responsible for all 5 countries, which brings many synergies but also complexity. Therefore, it is necessary to have an excellent understanding of both the Nordic and European legislation and the ability to interpret and apply regulations appropriately.
We expect you to be 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 simultaneously. Furthermore, you demonstrate excellent communication skills – written and verbal.
Preferably, you have a good flair for IT systems and, in general, a good understanding of technical IT tools.
Major accountabilities:
- Responsible for all life cycle management activities for your defined portfolio.
- Regulatory compliance of marketing authorization, updates/text management, prepare and ensure timely submission for products in the Nordics. Respond to requests from health authorities and provide approved texts for implementation in due time.
- Close collaboration with Supply Chain/Planning/QA/QC as well as Global RA with increased focus on business partnership.
- Act as an expert, ensuring compliance with regulatory guidelines, providing guidance on national and EU legislation within the regulatory field.
- Regulatory handling of change controls and deviations in GxP validated IT Systems.
Work Experience:
University degree with excellent results in a relevant field e.g., pharmaceutical or life sciences.
You will preferably have 1-5 years of experience from a position in regulatory affairs.
Skills:
- You are 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 verbal.
- Technical flair – e.g., experience/interest in working with (EDMS) Electronic Document Management System, (RIMS) Regulatory Information Management System.
Languages:
Mother tongue in either Danish, Swedish, or Norwegian and English both verbal and written.
You'll receive:
Competitive salary and bonus based on personal and company results; Pension Scheme; Health Insurance; Flexible working conditions with hybrid working policy; Employee recognition scheme; Development both professionally and personally; Learning about company processes.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024, and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed, and personal growth is supported
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Sandoz Network: If this role is not suitable for your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
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