Regulatory Affairs, Sandoz, Copenhagen, Denmark

RA Coordinator, 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 global company in a 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 proofreading of artwork, handle regulatory invoices and purchase orders, assist in regulatory administrative tasks handle regulatory change control in Track Wise and be back-up for Release of artwork. The activities relates to marketing authorisations of Global products (MRP/DCP and CP) in the Nordic countries.

You have a good understanding of both the Nordic and European legislation and have the ability to interpret and apply regulations appropriately. You have solid experience with QRD templates and Blue box texts. 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:

  • Proofreading of Mock Ups and package leaflets in accordance with Directives, EU Regulations and national guidelines of PIL and labelling for the Nordic countries
  • Handling of regulatory invoices and purchase orders
  • Handling of regulatory change controls in TrackWise
  • Assist RA Officers in regulatory administrative tasks, e.g. update of catalogue texts
  • Back-up for release of artwork within all therapeutic areas for Global products in the Nordics

 

Minimum requirements

What you’ll bring to the role:

  • Pharmaconomist or similar preferably with experience from pharmaceutical industry
  • Ideally minimum 2-3 years of experience from pharmaceutical industry
  • Detail oriented, structured and strong communication skills, mother tongue in one of the Nordic languages and English both verbal and written

 

Please apply here

 

 

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