Regulatory Professional
- Regulatory Affairs
- Denmark - 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 – and make a meaningful difference to our business.
About the department
In our department, consisting of 10 dedicated colleagues, we are responsible for all global regulatory activities on early diabetes and obesity projects, Glucagon and CMC activities for projects and products in the GLP-1 & Obesity area, including Victoza®, liraglutide Obesity, Glucagon® and s.c semaglutide. The premises for the department is a matrix structure where close collaboration with all departments within the Area is a prerequisite for success so this is what we do.
The job
We are currently looking for a regulatory professional with an interest and experience in CMC. You will join our team of specialists working with the development project s.c. semaglutide and the approved product Victoza. The development project is currently in early phase 3 development and Victoza is approved and on the market in many countries around the world.
In Regulatory Affairs, you’ll work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, project management and the challenges of international communication will be part of your busy workday. You’ll be expected to make an impact and to ask questions and challenge the status quo if that’s what it takes.
You will be involved in the s.c. semaglutide project where you will be working on the preparation, submission and approval of clinical trial applications all around the world. You will also be part of and work closely together with the rest of the s.c. semaglutide RA team on other project related activities. In addition you will be part of our team working on the approved product Victoza being involved in updates of the quality part of the product dossier through variations. You will provide advice to our stakeholders outside Regulatory Affairs on regulatory requirements to CMC changes and other inquires. You may also be involved in various projects related to the quality part of the dossier where you will work closely together stakeholders within and outside Regulatory Affairs.
Qualifications
We expect you to have a university degree in science and documented professional experience working with regulatory affairs and/or the pharma industry.
As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work even when the pressure’s on. You’re a strong team player, but you also enjoy working independently to challenge the status quo and find new solutions to the challenges you meet. You’re also a skilled communicator who is comfortable speaking and writing in English.
You have experience working with CMC from your current or earlier job, either within Regulatory Affairs or in other parts of the organisation.
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 Christina Rindshøj on +45 3075 9092.
Deadline
16 August 2013.
- Regulatory Affairs
- Denmark - 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 – and make a meaningful difference to our business.
About the department
In our department, consisting of 10 dedicated colleagues, we are responsible for all global regulatory activities on early diabetes and obesity projects, Glucagon and CMC activities for projects and products in the GLP-1 & Obesity area, including Victoza®, liraglutide Obesity, Glucagon® and s.c semaglutide. The premises for the department is a matrix structure where close collaboration with all departments within the Area is a prerequisite for success so this is what we do.
The job
We are currently looking for a regulatory professional with an interest and experience in CMC. You will join our team of specialists working with the development project s.c. semaglutide and the approved product Victoza. The development project is currently in early phase 3 development and Victoza is approved and on the market in many countries around the world.
In Regulatory Affairs, you’ll work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, project management and the challenges of international communication will be part of your busy workday. You’ll be expected to make an impact and to ask questions and challenge the status quo if that’s what it takes.
You will be involved in the s.c. semaglutide project where you will be working on the preparation, submission and approval of clinical trial applications all around the world. You will also be part of and work closely together with the rest of the s.c. semaglutide RA team on other project related activities. In addition you will be part of our team working on the approved product Victoza being involved in updates of the quality part of the product dossier through variations. You will provide advice to our stakeholders outside Regulatory Affairs on regulatory requirements to CMC changes and other inquires. You may also be involved in various projects related to the quality part of the dossier where you will work closely together stakeholders within and outside Regulatory Affairs.
Qualifications
We expect you to have a university degree in science and documented professional experience working with regulatory affairs and/or the pharma industry.
As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work even when the pressure’s on. You’re a strong team player, but you also enjoy working independently to challenge the status quo and find new solutions to the challenges you meet. You’re also a skilled communicator who is comfortable speaking and writing in English.
You have experience working with CMC from your current or earlier job, either within Regulatory Affairs or in other parts of the organisation.
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 Christina Rindshøj on +45 3075 9092.
Deadline
16 August 2013.