H. Lundbeck A/S 010 - Research and Development

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 .


 

Senior Regulatory Strategy Leader


Description
Regulatory Affairs in H. Lundbeck A/S is looking for an experienced global Senior Regulatory Strategy Leader with abilities to develop innovative regulatory strategies and establish novel regulatory pathways within the CNS area.

In Regulatory Affairs, you will be part of an organisation where we stand at the centre of regulatory project planning and execution from the earliest stages of drug development all the way through life cycle management.
Regulatory Affairs consists of 56 experienced colleagues in Lundbeck headquarters in Copenhagen (DK) and has a flat organisational structure with efficient and short decision pathways. The organization is highly matrixed and structured around cross-departmental teams with representation from all disciplines in the division.
The position is placed in the Department of Regulatory Strategy, which comprise 8 highly skilled and committed employees. We are accountable for defining innovative regulatory pathways and proactively drive the global regulatory strategies for Lundbeck’s portfolio of development projects and marketed products. Our goal is to ensure that well differentiated products reach the patients and the market with an attractive product label.

Your job and key responsibilities
You will be responsible for preparing, leading and implementing the regulatory development strategies of both small and large molecules for development projects with a high degree of complexity. You will represent RA in the global cross-functional project teams where you will focus on identifying regulatory opportunities and creating regulatory pathways for novel development directions within CNS.
In a typical day, your activities will range from discussing development strategy with the clinical lead, preparing for health authority interactions, looking into evidence generation strategies with your HEOR colleague, chairing a team meeting with your regulatory colleagues from key markets, to presenting a submission strategy for the cross-functional project team and/or Executive Management and Business Partners. Together with your affiliate Regulatory colleagues, you will be representing Lundbeck at key Health Authority meetings and interactions.
To accomplish this task, you will work highly cross-functionally with other key areas in Lundbeck, such as CMC, nonclinical, clinical, medical and commercial areas.
Some travel activity may be expected.
This position reports to the Director of Department of Regulatory Strategy and is based in the main R&D facility in Valby, Copenhagen.

We offer
The position offers the following opportunities:

  • High strategic influence on development activities from early to late stage drug development
  • Proactive cross-functionally interaction with various internal stakeholders at all levels and across geographies
  • Engagement and collaboration with external stakeholders including interactions with health authorities and business partners
  • Lead regulatory activities via dedicated regulatory sub-teams and cross-functional working groups
  • Take on challenging tasks in a global and cross-functional setting with responsibility to contribute directly to project deliverables
  • A head-quarter based position in a learning environment with excellent prospects for both professional and personal development

 

Qualifications
Our preferred candidate has the following qualifications and experience:

  • University credentials in a relevant life science or medical discipline with 8+ years’ experience in regulatory development strategy and/or relevant experience from employment at a Regulatory Agency
  • In-depth understanding of the drug development process across many phases of development with the ability to challenge beyond the regulatory field. Scientific understanding and knowledge from drug development of biologics is a clear advantage
  • Profound experience in preparing global regulatory development strategies in early and late stage development is a must, including a track record of successful hands-on experience for arranging and leading health authority interactions/scientific advice and global filings from several markets like US, EU, Japan and China
  • Thorough understanding of guidelines/legislation and awareness of global regulatory environment
  • Experience and network in the CNS field within Lundbeck’s focus disease areas are an advantage
  • Innovative mindset motivated by outgoing cross-functional collaboration and the ability to influence and interact effectively with internal and external customers
  • Ability to work structured, independently and effectively across functions and geographies and to lead and motivate regulatory sub-teams and cross-functional working groups
  • Team player with good interpersonal skills including excellent communication, messaging and presentation skills
  • Fluent in English both written and spoken

Further information
For further information, please contact Director Lene Kjær Kirstein on +45 30 83 22 85. Your application and CV should not be sent via email.
We also recommend that you have a look at our website.

Your application
Please click on the link below to apply for the job. Applications must be received no later than 25 January 2018.

 
 

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Region:
Region Hovedstaden

Job type:
Permanent

Working hours:
Full-time

Working days:
Day

Location:
Copenhagen

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Contacts:
Lene Kjær Kirstein
Telephone: +45 36432285
Mobile: +45 30832285

Company homepage:
http://www.lundbeck.com