Senior Regulatory Affairs Professional
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Søborg
- Regulatory
- Søborg
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all 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 to the befit for our business.
About the department
The RA CMC Established products is situated in the Novo Nordisk project house in Søborg together with other regulatory affairs functions. We are a group of 14 highly skilled product leads, project managers and RA CMC specialists responsible for the handling regulatory strategies of business critical and complex projects for established products within our Diabetes and Biopharm portfolio.
Our primary stakeholders responsible for Product & Process Development and, the global manufacturing sites together with Novo Nordisk Supply Chain planning. We are engaged in high potential projects to support the demand of increasing capacity and flexibility in our global manufacturing network and implement newest technology.
We also have a close collaboration with our RA CMC colleagues in Bangalore India who is responsible for the daily task of LCM support to stakeholders within Novo Nordisk global manufacturing sites, our affiliated offices and health authorities around the world.
The job
The job will not be easy, but it will be fun, and it will challenge and develop your business understanding and your ability to work in a global cross functional organization.
As a Senior Regulatory Professional, you are responsible for supporting high impact projects and support our RA CMC colleagues in Bangalore for two of Novo Nordisk established products within the Biopharm portfolio. You will support our primary stakeholders with regulatory pre-assessment and contribute with strategic regulatory input to project plans. The job involves a high degree of planning, coordinating and to some extend submitting variation applications.
The job requires that you continue your individual development and that you keep being updated within relevant regulatory and biotech disciplines and uses your external network to benchmark and bring up discussions with peers.
You will work 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. Some travel activities, -primary to Bangalore, are expected
Qualifications
You hold a university degree in natural science or similar and have a documented professional experience from a regulatory affairs position and/or the pharma industry, preferable 5-7 years. It will be an advantage if you have experience with biotechnology upstream & downstream processes.
You are organised, able to think out of the box, dare to take risks and exhibit a strong driver. You demonstrate winning attitude, keep your spirits high and stay calm even when under pressure. You are a strong team player whom is also able to work independently. Fluency in written and spoken English is a must.
Contact
For further information, please call Manager Jacob Larsen +45 3079 1441.
Deadline
10th November 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 28.10.2019, 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
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