Regulatory Affairs Associate at AstraZeneca Nordic Marketing Company - temporary position based in Tallinn
AstraZenecaEstonia - tallinnUpdate time: October 23,2020
Job Description

By 2025 the AstraZeneca Nordic Marketing Company aims to become a recognised leader in our core therapy areas and thus improving lives of millions of people. We will achieve this by driving excellent launches, building close collaboration and partnerships with stakeholders in the health care systems, and developing high performing teams. More information about AstraZeneca on www.astrazeneca.com
 

We are a fast-paced and evolving organization focused on excellence in science, brands and people. Regulatory Affairs Nordic work from offices in Södertälje(Swe), Copenhagen, Helsinki and Tallinn.

Medical & Regulatory function
 

In the Medical and Regulatory function in AstraZeneca Nordic, we work to aim for the highest patient safety, benefit, access of our drugs to patients and good quality from a market ethical perspective. The function covers several responsibilities within Medical Affairs, Medical Evidence, Regulatory Affairs, Patient Safety, Medical Information, Customer Complaints and Market Ethics.

An exciting opportunity has opened up in Helen Shennan’s team! A Temporary position as Regulatory Affairs Associate for Nordic-based operations in Tallinn, Estonia. We invite you to apply to join us!
 

You will be part of a team with the main task to ensure efficient and timely regulatory submissions directly to national health authorities, primarily for the Nordic markets but also manage some activities for the Baltic Marketing Company. You will mainly focus on areas in regulatory lifecycle management and provide regulatory expertise and support across organizations. The office is in Tallinn, Estonia.
 

You will:

  • Prepare, update and submit the product documentation needed for registration and maintenance of our Marketing Authorisations to the Health Authorities in the region
  • Communicate with Health Authorities on pending issues and changes in regulatory requirements; drive and develop key AstraZeneca specific regulatory questions and processes
  • Work with activities related to product labelling and packaging material
  • We work with continuous improvements as a tool to develop and simplify our business therefore active contribution to continuous improvements within the function is important.
     

It is essential that you:

  • Have University degree in Pharmacy or equivalent
  • Demonstrate experience with Regulatory work
  • Can communicate in English and Estonian, if you know any other Nordic language that's a plus
  • Have good knowledge of relevant legislation requirements and procedures
  • Contribute to the development of an effective team
  • Ensure personal competence development
     

We offer you a challenging and well-aimed work in a working environment with a high organizational culture, good colleagues, a continuous professional education and a motivating salary.
 

More information

Please don’t hesitate to contact Helen Shennan: +45 2325 2530

Please submit the application in English with CV and Letter of Motivation (including desired salary conditions) no later than the 8th November.

Date Posted

23-okt.-2020

Closing Date

08-nov.-2020

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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