Job opportunities

Regulatory Submission Publisher

Location

Region Hovedstaden

City

Copenhagen

Department

Research and Development

Application deadline

02 January 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 Submission Publisher your main responsibility areas will be:

  • Global operational activities related to compilation and publishing of all marketing applications (initial application, variations, renewals, PSUR etc.), including:
    • QC and clean-up of documentation for regulatory submissions
    • Compilation of regulatory documents
    • Provide guidance on standards and technical requirements in relation to publishing etc.
    • Participate in cross-organizational submission teams,
  • Management of our Regulatory Information Management System (RIMS – ArisGlobal Register), including:
    • Ongoing timely implementation of commitments to authorities and implementation of new initiatives from Authorities
    • Data entry and data quality activities

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:

  • Experience with electronic document management systems, publishing tools, basic knowledge of documents publishing/document management including, Adobe Acrobat is an advantage
  • Pharmacist or holds equivalent education/track record
  • Experience from working within Regulatory Affairs, Regulatory Processes and Operations is an advantage
  • Analytical and goal oriented
  • Fluent in English
  • Proficient in working with IT systems and databases
  • Service minded, structured and detail-oriented

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 Senior Scientist Mie Gøde Andersen on +45 30833775 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 2nd January 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 http://www.lundbeck.com/global/about-us/progress-in-mind.

Our approximately 5,300 employees in 55 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. We have research centres in China and Denmark and production facilities in China, Denmark, France and Italy. Lundbeck generated revenue of DKK 14.6 billion in 2015 (EUR 2 billion; USD 2.2 billion).

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

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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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