347294BR
Jun 21, 2022
Denmark

Job Description

20! You will be part of the Regulatory Affairs Department of 20 motivated, knowledgeable and highly skilled RA colleagues. The position is based in our Nordic affiliate located in Copenhagen, Ørestad.

Do you want to get an opportunity to make a difference within a dedicated global company with number 1 priority to pioneer patient access to better healthcare? Do you want to work in a challenging position that is characterized by high quality, result orientation and speedy realization of the goals? If yes, it might be you we are looking for!

In our life cycle management (LCM) Local Product team at Sandoz Nordic, we are looking for a new team member, who will become responsible of our marketing authorisations (approved via National, MRP/DCP or CP), and thus responsible for affiliate life cycle activities, of a defined portfolio.

With this position, you are given the opportunity to deep dive into the products and become a specialist 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, Labelling, 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.


Your responsibilities include, but not limited to:

• Responsible for all life cycle management activities for own defined portfolio
• Regulatory compliance of marketing authorizations. 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/labelling/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


Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• 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
• You are proactive, a teamplayer, 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 Norweigan and English both verbal and written
• Techincal 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, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Join us and help us reimagine medicine.

Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
SANDOZ
COMMERCIAL OPS EUROPE SZ
Denmark
Copenhagen
Research & Development
Full Time
Regular
No
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347294BR

Regulatory Affairs Officer, Sandoz, Copenhagen, Denmark

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