Regulatory Professional-Temp.
- Regulatory Affairs
- Denmark - Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine approved across the globe. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work but also quite challenging. Are you up for the challenge.
Ansøgningsfrist
The RA CMC Insulin and Oral Proteins Department is situated in the Novo Nordisk project house together with other regulatory functions in Søborg. We are a group of 28 highly skilled and dedicated people involved in maintaining the CMC part of the regulatory files and licenses as well as providing regulatory input during the various phases of drug development. We work very closely with stakeholders within Novo Nordisk headquarters, manufacturing sites outside Denmark, our affiliated offices and health authorities.The department is organised in two teams. We are currently looking for a Regulatory Professional to join our Site and Quality Support team in a 12 month temporary position. The team consists of 7 colleagues and is responsible for our manufacturing authorisations, Site Master Files and other RA activities related to our manufacturing sites. The responsibilities of the team cover activities on biopharm as well as insulin manufacturing sites; hence the function of the team is shared across the six project/product functional areas in Regulatory Affairs.
The Job
In the team you will be responsible for planning, coordinating and executing activities related to our manufacturing authorisations and ensure maintenance of documentation required for operation of our manufacturing facilities.As Regulatory Professional you will serve as the primary RA contact to the Danish Medicines Agency regarding our manufacturing authorisation and be responsive to the requirements entailed in maintaining the authorisation. This includes coordination and communication with many internal stakeholders. You will also be working closely with the internal inspection office, which is responsible for the coordination of health authority inspections.You will work in a fast-paced environment with tight deadlines, cross-departmental collaboration and deal with the challenge of international communication. You will be expected to make an impact and to ask questions and challenge the status quo if needed. You will report to the Team Leader of the Site and Quality Support Team.
Qualifications
We expect you to have a degree in science and experience within pharmaceutical production and/or quality assurance. Regulatory affairs experience is an advantage.You are organised, a good planner and a proactive networker. You show a winning attitude and keep your spirits high even when under pressure, and as a skilled communicator you can cooperate at any organisational level. You are comfortable speaking and writing in English as well as Danish.
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 call Jens Bjørn Nielsen at +45 3075 6120.
Deadline
15 June 2013.
- Regulatory Affairs
- Denmark - Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine approved across the globe. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work but also quite challenging. Are you up for the challenge.
Ansøgningsfrist
The RA CMC Insulin and Oral Proteins Department is situated in the Novo Nordisk project house together with other regulatory functions in Søborg. We are a group of 28 highly skilled and dedicated people involved in maintaining the CMC part of the regulatory files and licenses as well as providing regulatory input during the various phases of drug development. We work very closely with stakeholders within Novo Nordisk headquarters, manufacturing sites outside Denmark, our affiliated offices and health authorities.The department is organised in two teams. We are currently looking for a Regulatory Professional to join our Site and Quality Support team in a 12 month temporary position. The team consists of 7 colleagues and is responsible for our manufacturing authorisations, Site Master Files and other RA activities related to our manufacturing sites. The responsibilities of the team cover activities on biopharm as well as insulin manufacturing sites; hence the function of the team is shared across the six project/product functional areas in Regulatory Affairs.
The Job
In the team you will be responsible for planning, coordinating and executing activities related to our manufacturing authorisations and ensure maintenance of documentation required for operation of our manufacturing facilities.As Regulatory Professional you will serve as the primary RA contact to the Danish Medicines Agency regarding our manufacturing authorisation and be responsive to the requirements entailed in maintaining the authorisation. This includes coordination and communication with many internal stakeholders. You will also be working closely with the internal inspection office, which is responsible for the coordination of health authority inspections.You will work in a fast-paced environment with tight deadlines, cross-departmental collaboration and deal with the challenge of international communication. You will be expected to make an impact and to ask questions and challenge the status quo if needed. You will report to the Team Leader of the Site and Quality Support Team.
Qualifications
We expect you to have a degree in science and experience within pharmaceutical production and/or quality assurance. Regulatory affairs experience is an advantage.You are organised, a good planner and a proactive networker. You show a winning attitude and keep your spirits high even when under pressure, and as a skilled communicator you can cooperate at any organisational level. You are comfortable speaking and writing in English as well as Danish.
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 call Jens Bjørn Nielsen at +45 3075 6120.
Deadline
15 June 2013.