Senior Regulatory Professional - RA GLP-1 & NASH Projects
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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
RA GLP-1 & NASHProjects are responsible for the regulatory deliverables for clinical projects and life cycle management activities for Victoza® and Ozempic® products. We are nine dedicated and highly engaged employees working in the department. We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. 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 a Senior Regulatory Professional with a strong scientific background and a genuine interest in being part of the future within GLP-1 and NASH projects.
The job
As a Senior Regulatory Professional, you will be responsible for driving 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 be responsible for 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 contribute to the global regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to project team decisions. You will among others interact with project management, medical and non-clinical specialists, statisticians and medical writers. You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes across the organisation.
Qualifications
We expect you to have a Master of Science (life sciences) and/or PhD with 5-7 years of relevant working experience (e.g. regulatory sciences, clinical and non-clinical drug development, medical writing, clinical trial management). As a person you thrive in a busy environment; bring a 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.
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 Christoffer Wenzel Tornøe on +45 30 75 81 93.
Deadline
1 December 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 19.11.2019, 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 01. december 2019
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