Job opportunities

Regulatory Scientist

Location

Region Hovedstaden

City

Copenhagen

Department

Research and Development

Application deadline

29 September 2017

Description

Regulatory Scientist – Regulatory Dossier Management 
We are looking for a Regulatory Scientist to fill a vacant position in Dossier Management, a department within the Regulatory Affairs Division. Regulatory Dossier Management employs 17 highly skilled and committed colleagues involved in regulatory activities from early to late stage development projects and marketed products. Regulatory Dossier Management is also responsible for regulatory activities for clinical trials.

Your job and key responsibilities

  • Execution of global regulatory strategies for development projects (Phase I-IV) and marketed products
  • Preparation and maintenance of Clinical Trial Authorisation-, and Investigational New Drug applications
  • Managing global regulatory operational activities related to initial marketing authorisation applications as well as Life Cycle Management  

We offer
A stimulating and dynamic working environment with global reach, focused on innovating treatments for depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease. A working culture focused on partnership, cross-organisational collaboration, and development opportunities, professionally as well as personally. 

Qualifications
Our preferred candidate has the following personal and professional qualifications:

  • A university degree in science
  • Solid professional experience from a regulatory affairs position in pharma industry
  • Passion for Dossier Management activities and desire to develop within this area
  • Insight in regulatory requirements in preferably International Markets (e.g., but not limited to Asia)
  • Consistently achieving results, even under tough circumstances
  • Adapting approach and demeanour in real time to match the shifting demands of different situations
  • Building partnerships and working collaboratively with others to meet shared objectives
  • Shows proactivity and is solution oriented
  • Excellent organiser with a high personal drive
  • Demonstrates good communication skills orally as well as in writing
  • Is fluent in speaking and writing in English

Further information
For further information, please contact Director Afsaneh Abbariki, on +45 30 83 38 61or by email aab@lundbeck.com.

Your application
Please click on the link below to apply for the job. Applications must be received no later than 29 September 2017.

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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