Regulatory Professional - Biopharm

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Søborg

  • Regulatory
  • Søborg

Join Regulatory Affairs and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

About the department

The department “RA Haemophilia” is part of RA Biopharm in Regulatory Affairs and is situated in the Novo Nordisk project house together with other regulatory affairs functions in Søborg. We are a group of highly skilled and dedicated people involved in every clinical and non-clinical aspects concerning marketed products as well as projects in development within Haemophilia. The project portfolio is developing and in order to be able to handle the tasks and challenges within our area of responsibility we are looking for one more colleague for the department.

You will work with experienced and engaged colleagues and work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. In this dynamic environment, our dedicated group prepares worldwide regulatory strategies for submissions and is responsible for interactions with regulatory authorities.

The job

As a regulatory professional in RA Haemophilia, you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.

You will be a member of cross functional project teams responsible for deliverables during lifecycle management. You will interact with a variety of stakeholders from different departments and worldwide affiliates in Novo Nordisk. You will participate in the development of regulatory documentation to Health Authorities, including safety documents, variation applications, briefing packages for meetings with Health Authorities, clinical trial applications and clinical trial protocols.

Other responsibilities include ensuring that regulatory commitments are met, promotional materials are aligned with our labelling and that Investigator initiated studies are in accordance with the regulatory strategy. You are expected to provide regulatory input, be proactive and challenge and contribute to project team decisions.

You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes.

Qualifications

We expect you to have a university degree in science have 2-4 years of experience from the pharma industry.

As a person you thrive in a busy environment; bring can-do spirit and a healthy sense of humor to your work – even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations.

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Contact

For further information, please contact Karen Schumann +45 3079 0805 or Jane Møll Pedersen +45 3075 3759

Deadline

5. January 2020, however applications will be read and reacted upon as they come in.

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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 5.12.2019, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Apoteker
  • Søborg
  • Søndag den 05. januar 2020
Rapportér

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