Job Description Summary
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.
Job Description
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, 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
What you’ll bring to the role:
Essential Requirements:
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?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people 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 careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
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.
#Sandoz
Skills Desired
Documentation Management, Regulatory ComplianceSkills Required
- University degree in a relevant field, such as pharmaceutical sciences or life sciences
- Experience in regulatory affairs; preferably 1–5 years
- Ability to establish and discuss regulatory approaches, including risks and benefits, for life-cycle management activities
- Strong written and verbal communication skills
- Native-level Danish, Swedish, or Norwegian language proficiency
- Written and verbal English proficiency
- Technical aptitude, including experience or interest in EDMS, RIMS, or similar systems
Sandoz Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.
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Healthcare Strength — Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
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Retirement Support — A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
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Equity Value & Accessibility — Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.
Sandoz Insights
What We Do
Sandoz is the global leader in generic and biosimilar medicines. Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance. We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
