Job opportunities

Regulatory Data Manager

Location

Region Hovedstaden

City

Copenhagen

Department

Research and Development

Application deadline

30 April 2018

Description

The position is a temporary until 31-Jul-2019 and is part of Regulatory Affairs, Regulatory Submission Management & Telematics Department

The Regulatory Submission Management & Telematics Department is responsible for the critical operational activities in connection with compilation and submission of marketing authorisation applications, regulatory data management and implementation of labelling and manufacturing changes in the production area.
Furthermore the department is responsible for ensuring that all major information and documentation systems within Regulatory Affairs & Pharmacovigilance, are working successfully and in harmony.
The Regulatory Submission Management & Telematics Department is part of Regulatory Affairs. The position is based in Lundbeck’s headquarters in Valby (Copenhagen, Denmark) and the department consists of 16 highly experienced employees.

Your job and key responsibilities
As Regulatory Data Manager your main responsibility area will be:

  • Management of our Regulatory Information Management System (RIMS – ArisGlobal Register), including:
    • Data entry
    • Data quality activities
    • Ongoing timely implementation of commitments to authorities and implementation of new initiatives from Authorities

Furthermore, you will be involved in tasks and projects within the departments responsibility areas.
On a daily basis you will co-operate with colleagues in Regulatory Affairs globally and colleagues throughout the Lundbeck Value Chain. The job can, at times, be fast paced and the tasks are often associated with tight deadlines.

We offer
We offer you the opportunity to work in a truly global environment with exciting activities and an open working atmosphere where you will be part of a dynamic team.

Qualifications
Our preferred candidate has the following professional qualifications:

  • Works structured and detail-oriented.
  • Proficient in working with IT systems and databases
  • Analytical and goal oriented
  • Fluent in English
  • Experience from working within Regulatory Affairs, Regulatory Processes and Operations is an advantage

If you are a recently qualified Pharmacist, Engineer or hold a similar education, and have an interest in working with regulatory processes and systems in a pharma company, we also encourage you to apply.

Further information
For further information, please contact Regulatory Specialist, Angelina Gindeberg on +45 30832292 or Senior Director, Preben Klavsen on +45 30833627. Your application and CV should not be sent via email.
We also recommend that you have a look at our website, www.lundbeck.com.

Your application
Please click on the link below to apply for the job. Applications must be received no later than 30-Apr-2018.

Apply for the job here

Please apply for this job from a desktop/laptop computer.

Lundbeck is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.

An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.

Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. Our research centre is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 17.2 billion in 2017 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via our LinkedIn company page.

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Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with psychiatric and neurological disorders.

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