Job opportunities

Regulatory Data Manager

Location

Region Hovedstaden

City

Copenhagen

Department

Research and Development

Application deadline

30 April 2018

Description

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 critical global product and submission data and to ensure that the authority approved commitments are communicated to and implemented in Lundbeck’s production. This includes:
    • Evaluation and approval of all requests for changes to the packaging material and artwork
    • Contribute to successful launches of new products.

Further you will be involved in tasks and projects within Regulatory Submission Management & Telematics other responsibility areas including management of our Regulatory Information Management System and operational activities related to compilation and publishing of all marketing applications.
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: 

  • Pharmacist or holds equivalent education/track record
  • Experience from working with the Regulatory Affairs area, Regulatory Processes and Operations
  • Experience with electronic document management systems, publishing tools, basic knowledge of documents publishing/document management including, Adobe Acrobat is an advantage
  • Service minded, structured and detail-oriented
  • Analytical and goal oriented
  • Fluent in English
  • Proficient in working with IT systems and databases, preferable Regulatory Information Management Systems, SAP and processes related to tracking of critical product data

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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