Regulatory Professional - RA Diabetes and Obesity Projects
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Søborg
- Regulatory
- Søborg
Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to gain regulatory approval of Novo Nordisk’s medicines 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 innovative place to work.
About the department
RA Diabetes & Obesity area is responsible for regulatory strategies for diabetes and obesity projects in development and life cycle management (LCM) phases. We are 50+ dedicated and highly engaged employees working in the area across four departments. We work as an integrated part of the global development and research projects and play a key role in the cross-functional teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plans. We drive label development, health authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams.
We are currently looking for new colleagues with a strong scientific background who has a genuine interest in being part of the future bringing innovative medicines to patients worldwide.
The position
As a Regulatory Professional, you will be responsible for driving and supporting several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk.
You will participate in the development of regulatory documentation for submission to health authorities, including briefing packages for meetings with health authorities, clinical trial applications, clinical trial protocols and reports and regulatory file for marketing authorisation.
Furthermore, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will among others interact with medical and non-clinical specialists, statisticians and medical writers.
Qualifications
We expect you to have a university degree (M.Sc. or equivalent) in life science preferably complemented by a PhD and with some relevant working experience (3-4 years).
As a person you thrive in a busy environment; bring can-do spirit and a healthy sense of humour 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. You are a skilled communicator who can cooperate at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis.
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 Mette Pierri Stensler-Thomsen at +45 3077 5592 or Vibeke Hatorp at +45 3075 5697.
Deadline
29 March 2020.
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 13.3.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg
- Søndag den 29. marts 2020
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