Regulatory Affairs Associate
- Regulatory Affairs
- Denmark - Søborg
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approvals in all our markets. Regulatory Affairs is a fast-changing and complex landscape, therefore, a high level of professionalism and a thorough business understanding is essential for the employees in our unit in order to make a difference to our business.
We are currently looking for a Regulatory Associate, with an interest in CMC to join our team working with all tasks related to ensure that all our marketed products and our early development projects are in compliance.
About the department
Our team (Regulatory Affairs CMC Insulins and Oral Proteins) is lifting tasks to ensure succesfull lifecycle management of our marketed insulin products as well as ensuring succesfull clinical trial applications for products handled in our team. Our team consist of 18 employees and we are located in Søborg.
The job
In Regulatory Affairs, you will work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration and the challenges of international communication. Your work day will consist of preparing and providing documentation for authorities, support the team, handle various IT systems for archiving of documents and information, and some administrative tasks, will be part of your busy workday.
You will be expected to make an impact, ask questions and challenge the status quo if that is what it takes. You will find that Novo Nordisk offerst first-rate professional training, relevant support and talented, friendly colleagues working in an enjoyable atmousphere.
Qualifications
Your background education is Pharmaconomist, B.Sc. in English, or equivalent. You have preferable experience from working in regulatory affairs or similar area. You have a flair for IT systems and experience with MS Office as you will be responsible for managing data entry and electronic filing in our various databases and document management systems as well as assist with preparation, submission and approval of worldwide aplications covering insulin products in close collaboration with your colleagues. You communicate in written business English and are comfortable using English in your daily work.
On a personal level, you thrive in a busy environment and bring a can-do attitude to your work. You have good coordination and planning skills and maintain a healthy sense of humour even when the pressure is on. Your are a strong team player, but also enjoy working independently. You are able to challenge the status quo and find new solutions to the challenges you may face. You are systematic, flexible in your approach and goal oriented, and have a quality mindset.
At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.
Contact
For further information, please contact Lene Vindelev Dalsgård Nielsen at +45 3075 3358.
Deadline
30 November 2013
- Regulatory Affairs
- Denmark - Søborg
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approvals in all our markets. Regulatory Affairs is a fast-changing and complex landscape, therefore, a high level of professionalism and a thorough business understanding is essential for the employees in our unit in order to make a difference to our business.
We are currently looking for a Regulatory Associate, with an interest in CMC to join our team working with all tasks related to ensure that all our marketed products and our early development projects are in compliance.
About the department
Our team (Regulatory Affairs CMC Insulins and Oral Proteins) is lifting tasks to ensure succesfull lifecycle management of our marketed insulin products as well as ensuring succesfull clinical trial applications for products handled in our team. Our team consist of 18 employees and we are located in Søborg.
The job
In Regulatory Affairs, you will work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration and the challenges of international communication. Your work day will consist of preparing and providing documentation for authorities, support the team, handle various IT systems for archiving of documents and information, and some administrative tasks, will be part of your busy workday.
You will be expected to make an impact, ask questions and challenge the status quo if that is what it takes. You will find that Novo Nordisk offerst first-rate professional training, relevant support and talented, friendly colleagues working in an enjoyable atmousphere.
Qualifications
Your background education is Pharmaconomist, B.Sc. in English, or equivalent. You have preferable experience from working in regulatory affairs or similar area. You have a flair for IT systems and experience with MS Office as you will be responsible for managing data entry and electronic filing in our various databases and document management systems as well as assist with preparation, submission and approval of worldwide aplications covering insulin products in close collaboration with your colleagues. You communicate in written business English and are comfortable using English in your daily work.
On a personal level, you thrive in a busy environment and bring a can-do attitude to your work. You have good coordination and planning skills and maintain a healthy sense of humour even when the pressure is on. Your are a strong team player, but also enjoy working independently. You are able to challenge the status quo and find new solutions to the challenges you may face. You are systematic, flexible in your approach and goal oriented, and have a quality mindset.
At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.
Contact
For further information, please contact Lene Vindelev Dalsgård Nielsen at +45 3075 3358.
Deadline
30 November 2013