Regulatory Affairs Specialist

Job Description
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape

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.

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, 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

Essential Requirements
What you'll bring to the role:

• University degree on relevant field e.g pharmaceutical or life sciences
• You will preferably have 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 for the position.
• 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
• 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.

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.

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