Regulatory Professional, RA CMC & Device

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  • Regulatory
  • Bagsværd

In Regulatory Affairs (RA) we make medicine available to patients all over the world by ensuring rapid regulatory approval in all of our markets. Regulatory Affairs is a fast changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world and make a meaningful difference to our patients and business.

This is a 12 months temporary position.

About the department

The RA Chemistry, Manufacturing, and Controls (CMC) and Device area is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are approximately 80 highly skilled and dedicated people involved in every CMC and Device aspect concerning the regulatory files and licenses, as well as providing regulatory input during the various phases of drug development. We work very closely with stakeholders within Novo Nordisk headquarters, manufacturing sites outside Denmark, our affiliated offices and health authorities around the world.

The position

As RA CMC & device professional you are responsible for the life cycle management activities of the marketing authorisations of Novo Nordisk products. In addition, you maintain regulatory compliance by providing assessment of the regulatory impact of changes made in the production and as relevant negotiate and report these changes to health authorities globally.

You will be responsible for planning, coordinating and submitting variation applications and to provide regulatory input in the cross functional projects you are involved in. On a daily basis, you will support affiliate offices in responding to requests from authorities and reviewing the documentation needed for submission. You will review and assess change requests and play an important role in ensuring work processes are working smoothly and optimally.

RA CMC & Device works in a fast-paced environment with tight deadlines, cross-departmental collaboration and deal with the challenge of international communication. The atmosphere is informal and good humour is always welcome.

For more information about the job please see these small videos:

https://video.novonordisk.com/secret/52385973/21be08dc82d9f18f9ba563c3ea32bf2a
https://video.novonordisk.com/secret/52386223/33a55c4c8ae0155ba8b753e41938ca72
https://video.novonordisk.com/secret/52386417/cb1930dbbe7e5e1cdb934f3aac8fa3fc

Qualifications

We seek a curious, dynamic and highly skilled newly graduated person with a university degree in Science. As person you should be organised, a good planner and exhibit drive. You demonstrate a winning attitude and keep your spirits high even when under pressure. You are a strong team player and can also work independently.

Working at Novo Nordisk

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact

For further information, please contact Nicolai Listov-Saabye at +45 3075 4135 or Sabine Tarp at +45 3075 5404.

Deadline

20 August 2019.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


Information og data

Denne ledige stilling har jobtypen "Kemiker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Bagsværd.

Jobbet er oprettet på vores service den 31.7.2019, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Kemiker
  • Bagsværd
  • Tirsdag den 20. august 2019
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