Job Description
Major accountabilities:
- Responsible for all life cycle management activities for own defined portfolio
- Regulatory compliance of marketing authorization, 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 as well as Global RA with increased 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
Minimum Requirements
Work Experience:
- University degree with excellent results on relevant field e.g pharmaceutical or life sciences
- Your 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 verbally
- 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 where personal growth is supported!
Join us!
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 to 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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