Job opportunities

Regulatory Senior Scientist

Location

Region Hovedstaden

City

Copenhagen

Department

Research and Development

Application deadline

10 August 2018

Description

We are looking for a Regulatory Senior Scientist to fill a vacant position in Dossier Management, a department within the Regulatory Affairs Division. Regulatory Dossier Management employs 16 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:

  • Leading execution of global regulatory strategies for Lundbeck development projects and products, hereunder
    • submission of initial marketing authorisation applications as well as handling requests from the Competent Authorities during the assessment of the dossier 
  • Providing regulatory guidance taking into consideration local regulatory requirements
  • Participating in cross-functional working groups bridging knowledge across the Regulatory Affairs organisation and Product Team
  • Preparing and maintaining Clinical Trial Authorisation-, and Investigational New Drug applications for Product Development activities hereunder
    • ability to provide regulatory expertise in a cross-functional Study Management Team to ensure that study decisions are in line with overall global strategy

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:

  • Has a university degree in science
  • Minimum 7 years professional experience from a regulatory affairs position in pharma industry
  • Passion for Dossier Management activities and desire to develop within this area
  • Consistently achieving results, even under tough circumstances
  • Adapting approach and demeanor in real time to match the shifting demands of different situations
  • Building partnerships and working collaboratively with others to meet shared objectives
  • Demonstrates very good presentation skills
  • Demonstrates analytical thinking
  • Demonstrates excellent communication skills, orally and in writing  
  • Has the ability to actively influence internal and external stakeholders ensuring high quality regulatory dossiers
  • Shows proactivity and is solution oriented
  • Excellent organiser with a high personal drive
  • 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 10 August 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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