Job opportunities

Regulatory Biopharmaceuticals Senior Specialist

Location

Region Hovedstaden

City

Copenhagen

Department

Research and Development

Application deadline

21 January 2019

Description

Do you have profound experience with regulatory CMC for biopharmaceuticals?
Would you like to share your experience and be part of building up expertise within biopharmaceuticals across Lundbeck?
Then you might be the new colleague we are looking for.

Lundbeck is a medium-sized global research based pharmaceutical company, focusing on development of treatments within the four diseases areas, Depression, Alzheimers disease, Parkinsons disease and schizophrenia.
The pipeline covers both small molecules and biopharmaceuticals (primarily monoclonal antibodies), and Lundbeck wants to further strengthen the biopharmaceuticals field across the organisation.

Regulatory CMC is a department within Regulatory Affairs in R&D, responsible for all regulatory CMC related activities for all Lundbeck’s development projects and approved products world-wide.
We are a dedicated team consisting of the Head of Department and 7 employees including the new position, working in an open learning atmosphere.
Regulatory Affairs in Lundbeck consists of 5 departments with altogether around 65 employees.

The position is in Lundbeck Headquarters in Valby.

Your job and key responsibilities
Lundbeck has traditionally worked with small molecules, but we are now also aiming to develop the competences necessary to be a key player in development of biopharmaceuticals (such as monoclonal antibodies). You will have a key role in this new strategy.

You will be reporting to the Head of Department.
In your new job, you will be:

  • Responsible for all Regulatory CMC activities on biopharmaceuticals development projects
  • Responsible for developing the Regulatory CMC strategy for assigned projects
  • Driving the preparation of CMC part of IND/IMPD/BLA/MAA’s, authority meeting preparations, etc

You will be:

  • Working in close cooperation with colleagues across the organisation, such as Research, Chemical & Pharmaceutical Research and CRO’s
  • Have a central position as advisor for both Regulatory Affairs and other R&D stakeholders within the biopharmaceuticals field.
  • Be part of Regulatory Affairs teams participating in development of the global regulatory strategy
  • Educating your colleagues in the department
  • Covering global regulatory requirements with focus on US, EU, Japan and China

A few travel days will be expected.

We offer
In the position, you will have the opportunity to be a central part of developing a strong and highly competent biopharmaceuticals team in Regulatory Affairs, and shaping the biopharmaceuticals environment at Lundbeck together with colleagues within and outside RA.

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

  • hold a relevant university degree in life science
  • have extensive knowledge on biopharmaceuticals
  • preferably experience with drug-device combinations
  • have a minimum of 6 years’ experience within the field
  • like to share knowledge with colleagues and educate others
  • demonstrate analytical, conceptual and strategic thinking as well as excellent communication skills
  • outward-going and able to influence others in a positive way
  • have a friendly attitude with an open and flexible pro-active approach to the assignment

Further information
For further information, please contact Karen Fich on kfi@lundbeck.com or +45 30 83 25 87.
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 21 January 2019.

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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