Regulatory Affairs Officer, Sandoz, Copenhagen, Denmark

Novartis

Fuldtidsjob
Storkøbenhavn
Øresundsregionen

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Job ID

268094BR

Position Title

Regulatory Affairs Officer, Sandoz, Copenhagen, Denmark

Job Description

Regulatory Affairs Officer, Sandoz, Copenhagen, Denmark

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 in Ørestad.

Do you want to get an opportunity to make a difference within a dedicated global company in a challenging position that is characterized by high quality, result orientation and speedy realization of the goals? At Sandoz Nordic we have a globally aligned, strategic, efficient and collaborative regulatory function. You will be responsible for life cycle management (LCM) of our marketing authorizations with responsibility within own assigned therapeutic areas in the LCM Global Product team. The life cycle activities relates to marketing authorisations of Global products (MRP/DCP and CP) in the Nordic countries.

You have an excellent understanding of both the Nordic and European legislation and have the ability to interpret and apply regulations appropriately. You are energetic with positive energy that you like to share with your colleagues; you are self-motivating and thrive in a fast-paced environment. You manage work distribution within given timelines with an appropriate sense of urgency without undermining quality along with working effectively and collaboratively across the organization. You are a self-confident team player, but are also able to work independently to plan, structure and coordinate your tasks. 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:

• End-2-End ownership for own defined portfolio of assigned therapeutic areas in RA LCM
• Regulatory compliance of marketing authorizations. Safety updates/text management, prepare and ensure timely submission of national texts and mock-ups for Global 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 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 TrackWise, review and approval of Product Specific Annex (PSA) and Pre Launch Check List (PLC)

Minimum requirements

What you’ll bring to the role:

• University degree with excellent results on relevant field e. g pharmaceutical or life sciences
•Ideally 1-3 years of experience in Regulatory Affairs
•Strong communication skills, mother tongue in one of the Nordic languages and English both verbal and written
•Excellent IT skills

You’ll receive:
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

Why consider Novartis?

927 million. The number of lives we touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives.

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks. And where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Join us and help us reimagine medicine.

Division

SANDOZ

Business Unit

COMMERCIAL OPS WE SZ

Location

Denmark

Site

Copenhagen

Company/Legal Entity

SDZ DNK

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular


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