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Regulatory Affairs Officer

Join the Regulatory Affairs team in a truly global organization, #1 within biosimilars and generic antibiotics

Your new company

Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in generic antibiotics, the foundation of global healthcare systems, and biosimilars, the “cutting edge” of innovative off-patent medicines. With a mission to discover new ways to improve and extend people’s lives, Sandoz employs over 12,000 employees worldwide, has a global portfolio comprising more than 1000 molecules and products reaching more than 500 million patients. 

Sandoz in the Nordics employs 150 people and the office is located in Copenhagen in Ørestad.

Your new role

Sandoz is looking for a highly professional and motivated Regulatory Affairs Officer for life cycle management (LCM) of its marketing authorizations with responsibility within own therapeutic areas. 
The open position is located in the Global RA Life Cycle Management team covering a portfolio that consist of marketing authorizations maintained within Sandoz. The life cycle activities relates to marketing authorizations (MRP/DCP and CP) in the Nordic countries.

This unique role as a Regulatory Affairs Officer will provide the right candidate with responsibility for regulatory compliance of marketing authorizations and safety updates of national texts. You will enjoy a high level of collaboration with Supply Chain, Planning, labelling, QA/QC with increased focus on business partnership. You will moreover be in charge of updating the relevant databases, handling change controls and deviations in Trackwise, and responding to request from authorities. Lastly, you will have the opportunity to participate in the implementation of a new structure with e-2-e ownership in RA LCM Global Product team and be the first point of contact as a strong commercial business partner.

What you’ll need to succeed

The preferred candidate holds a Master’s degree in Pharmacy or a relevant education in Life Sciences combined with at least 5 years of professional experience within regulatory affairs. You have an understanding of both the Nordic and European legislation and have the ability to interpret and apply regulations appropriately. 

You are energetic, detail-oriented and thrive in a fast-paced environment and show the ability to meet timelines reliably and without undermining quality. Besides, you are working effectively and collaboratively across the organization. You are a self-confident teamplayer, but are also able to work independently to plan, structure and coordinate your tasks. You are a fast learner, able to handle multipe tasks at the same time. Furthermore, you demonstrate excellent communication skills both written and verbal, and are fluent in at least one of the Nordic languages as well as English. 

What you’ll get in return 

Sandoz offers a challenging position within a dedicated company that is characterized by high quality, result orientation and speedy realization of the goals. Sandoz has a globally aligned, strategic, efficient and collaborative regulatory function.

What you need to do now

If you are interested in this role, forward a copy of your CV and cover letter in English and in one document. If you have any questions you are welcome to contact Recruitment Consultant Céline Konrad on +45 29 36 88 16.

Hays Denmark is part of Hays Plc, which is listed on London Stock Exchange (FTSE 250). Hays Plc is the world's leading recruiting experts in qualified, professional and skilled work.

We operate across the private and public sectors, dealing in permanent positions, contract roles and temporary assignments. We are market leaders in the UK and Australia, and one of the market leaders in Continental Europe. As of September 2011, the Group employed 7,600 staff operating from 255 offices in 31 countries across 20 specialisms.

Our combination of deep expertise across a wide spectrum of specialised industries and professions makes us unparalleled recruiters in the world of work.

Hays Specialist Recruitment A/S has operated in Denmark since 2008. We specialise in following areas of specialism: Accountancy & Finance, Banking, Construction & Property, Engineering, HR, Insurance, IT, Legal, Logistics, Life Sciences and Sales & Marketing. For more information see www.hays.dk

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København

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