Senior Regulatory Professional
- Regulatory Affairs
- Denmark - Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicines 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?
The Department
RA-Inflammation & Growth Hormone is part of Regulatory Affairs. In our area we are a dedicated and diverse team of 17 people located in Søborg, Denmark and 5 people currently located in Princeton, USA. As a team, we are breaking new ground within the therapeutic areas of inflammation and growth hormone. In this dynamic environment, our dedicated group prepares the regulatory strategies and is responsible for global interactions with regulatory authorities. We work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. Together we go an extra mile to succeed.
The Job
The position is situated in Søborg and will be part of a team of Project Managers, other experienced Regulatory Professionals and Associates. Your role will be to diligently secure the clinical input to global regulatory strategies and submissions. You will plan, coordinate and review the clinical regulatory documentation and chair internal working groups as our primary sparring partner for the clinical development organisation. To this end, you will work closely with the Regulatory Project Manager who is overall responsible for the regulatory part of our projects. In addition, you will be part of cross functional teams sharing your knowledge and getting new ideas. You will report to the department director.
Qualifications
As a minimum, we expect you to have a biology/health science university degree plus regulatory experience from pharmaceutical development including late stage clinical development. Preferably, you hold a PhD or you can document similar solid scientific understanding. You have successfully worked in project teams respecting the contribution of everyone. You have demonstrated that you are organised, detail-oriented and a proactive problem-solver. You communicate well and are completely comfortable speaking and writing English and can deal with the challenges of international communication.On a personal level, you thrive in busy and changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions.
At Novo Nordisk, your skills, commitment and ambition help us change lives for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.
Contact
For further information, please call Lars Wichmann Madsen +1 609-819-6572 (US East coast time).
Deadline
8 September 2013
- Regulatory Affairs
- Denmark - Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicines 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?
The Department
RA-Inflammation & Growth Hormone is part of Regulatory Affairs. In our area we are a dedicated and diverse team of 17 people located in Søborg, Denmark and 5 people currently located in Princeton, USA. As a team, we are breaking new ground within the therapeutic areas of inflammation and growth hormone. In this dynamic environment, our dedicated group prepares the regulatory strategies and is responsible for global interactions with regulatory authorities. We work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. Together we go an extra mile to succeed.
The Job
The position is situated in Søborg and will be part of a team of Project Managers, other experienced Regulatory Professionals and Associates. Your role will be to diligently secure the clinical input to global regulatory strategies and submissions. You will plan, coordinate and review the clinical regulatory documentation and chair internal working groups as our primary sparring partner for the clinical development organisation. To this end, you will work closely with the Regulatory Project Manager who is overall responsible for the regulatory part of our projects. In addition, you will be part of cross functional teams sharing your knowledge and getting new ideas. You will report to the department director.
Qualifications
As a minimum, we expect you to have a biology/health science university degree plus regulatory experience from pharmaceutical development including late stage clinical development. Preferably, you hold a PhD or you can document similar solid scientific understanding. You have successfully worked in project teams respecting the contribution of everyone. You have demonstrated that you are organised, detail-oriented and a proactive problem-solver. You communicate well and are completely comfortable speaking and writing English and can deal with the challenges of international communication.On a personal level, you thrive in busy and changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions.
At Novo Nordisk, your skills, commitment and ambition help us change lives for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.
Contact
For further information, please call Lars Wichmann Madsen +1 609-819-6572 (US East coast time).
Deadline
8 September 2013