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Graduate Regulatory Affairs - Regulatory Dossier Management

 
Requistion ID:  850
Location: 

Copenhagen, N/A, DK

Date: 
 

Regulatory Affairs Graduate – Regulatory Dossier Management

Are you looking for the next step to kick-start your transition from being a student to becoming a young professional within Regulatory Affairs? Then join our Lundbeck Graduate Program 2020.

 

Lundbeck offers a great workplace that is based on a flat structure, and a collaborative working environment based on respect and equality. We employ dedicated colleagues and encourage continuous development. Together, we create the ideal conditions for you and your job, so we can create better conditions for patients.

 

As part of your two-year graduate journey at Lundbeck you will be exposed to various parts of the business and encounter many exciting challenges across the company. The learning curve will be steep and we expect a lot from you, but in return we offer a program that will empower you to grow both on a professional and personal level.

 

Regulatory Affairs in Lundbeck

 

Regulatory Affairs leads the wider Lundbeck organization towards global regulatory product approvals with commercially attractive labeling and ensures compliance with company policy, national regulations and laws through the development, registration and post-approval phases.

We stand at the centre of project planning and execution from the earliest stages of drug development all the way through life cycle management. We collect, collate and evaluate scientific data which confirms the quality, safety and efficacy of our medicines – all while keeping track of changing global health authority requirements.

 

Regulatory Affairs includes a wide range of responsibilities and fields of expertise (Science & Strategy, CMC, Dossier Management, Labeling and Business Operations), and you will experience all of them on this graduate career path.

 

RA is part of a bigger organization consisting of RA, Medical Documentation and R&D Quality Assurance including 231 experienced colleagues in Lundbeck headquarters in Copenhagen (DK) and has a flat structure with efficient and short decision pathways. The RA organization is highly matrixed and structured around cross-functional Focus Teams with representation from all departments in the division.

You will become part of the Regulatory Dossier Management department and work in an exciting international, fast-paced and dynamic environment. The variety of challenging responsibilities will help develop talents into becoming future leaders within the area.

 

 

Your job and the journey

Your job will be to execute regulatory strategies for development compounds and/or new products in LCM, hereunder prepare Clinical Trial Authorization and Investigation New Drug applications in addition to support operational activities for established products.

 

While being on the program you will participate in a wide range of development activities among others you will have the opportunity to work on two short-term assignments of 3-4 months duration in two other departments, the Dossier Management collaborates closely with. The assignments will help you to understand the link between the Science and the Regulatory discipline in order to facilitate the dialogue with the Health Authorities and increase the approvability success of our global marketing authorisation applications.

 

You will be working mainly in the Regulatory Dossier Management and work with experienced colleagues in this field. A mentor will be nominated in the respective departments where you do your assignments to give you guidance and direction during this period.

 

During the program you will participate in a wide range of development activities on your own as well as with other graduates - everything designed to guide you through the program, making sure you are on track and able to unfold your potential.

 

Qualifications

Our preferred graduate has the following qualifications:

  • A Master’s degree in a relevant field with a maximum of one-year post-academic work experience
  • Above average academic achievements and excellent English language skills
  • Theoretical and preferably practical insights into best-in-class Procurement Concepts, Supplier Relationship Management (SRM), Contract Management, Value Management and Measurement
  • Strong project management skills
  • Strong IT proficiency
  • You have ambitions and push yourself to achieve results
  • You are eager to learn, contribute and apply knowledge
  • You are comfortable leading change and managing upwards
  • You are proactive, and a self-starter seeking new ways to grow and be challenged through formal and informal development channels
  • You build partnerships and work collaboratively with others to meet shared objectives
  • You actively seek new ways to grow and be challenged using both formal and informal development channels
  • You adapt your approach and demeanour in real time to match the shifting demands of different situations
     

Further information

Join our Open House event on January 28th 2020 at Lundbeck’s Headquarter in Valby. Here you will get a chance to interact with Managers from the relevant areas and hear more about the graduate positions.

 

Read more and sign up for the event on our website: https://lundbeck.com/global/career/graduate-program/graduate-open-house.

 

For further information about the program and how to apply, please visit our website: http://www.lundbeck.com/global/career/graduate-program, and follow us on LinkedIn, Instagram and Twitter.

If you could not find the answer to your question on our website, do not hesitate to send an email to graduate@lundbeck.com.


Your application

Please click on “Apply now” to apply for the position. Applications must be received no later than February 9th, 2020. We are looking forward to receiving your application

 

 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.


An estimated 700 million people worldwide are living with brain diseases 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 brain diseases – 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 programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 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 LinkedIn.