Regulatory Affairs Specialist/Senior Specialist

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 Compliance