Regulatory Affairs Specialist

Job Description Summary
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!

Job Description
We are looking for a new regulatory colleague for our life cycle management (LCM) Product team at Sandoz Nordic. Here, you will be responsible of 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 the best sparring partner possible for your assigned products. Especially the latter is important, as you will be working in a close collaboration across the organization, and in particular with Supply Chain/Planning, Global RA and QA/QC. This will give you a unique insight to the business and various workflows.

Being a Nordic affiliate, the role is with responsibility of all 5 countries, which bring many synergies but also complexity. Therefore, it is needed 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 are 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 are able to handle multiple tasks at the same time. Furthermore, you demonstrate excellent communication skills – written/verbal.

Preferably, you have good flair of IT systems and in general, a good understanding of technical IT tools.

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)

#Sandoz

Skills Desired
Clinical Study Reports, Data Analysis, Documentation Management, Lifesciences, Operational Excellence, Regulatory Compliance

Location: Copenhagen (Sandoz)