RA SpecialistSenior Specialist

Copenhagen - Denmark

Monthly Salary: Not Disclosed

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

Join us the future is ours to shape!

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

What youll 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.

Youll 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.

#Sandoz

Skills Desired

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

Required Experience:

Senior IC

Job Description SummaryJoin us the future is ours to shape!Job DescriptionSandoz 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 opportunit...