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 the department we are a dedicated team of 17 people located in Søborg, Denmark and 6 people currently located in Princeton, USA.
The department covers both products under development and marketed products in the area of inflammation and growth hormone. The department is responsible for interactions with Health Authorities including meetings, submission of clinical trial applications and application for and maintenance of marketing authorisations. We work closely with a diverse range of stakeholders within Novo Nordisk headquarters, our affiliated companies and global Health Authorities.
The Job
The position will be situated in Søborg and you will work in close collaboration with Project Managers, other experienced Regulatory Professionals and Associates. In the team you will be responsible for planning and executing clinical regulatory activities related to your projects. You will plan, coordinate, review and provide sparring in relation to the clinical regulatory documentation. You will also be responsible for preparing and conducting internal meetings and be the point of contact for the clinical development organisation. You will provide clinical regulatory input to strategies, clinical trial applications and meetings with health authorities. You will work closely with the Regulatory Project Manager who is overall responsible for the regulatory input to our projects. Furthermore, you will be part of cross functional teams within Regulatory Affairs. 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 significant regulatory support to clinical phase 3 and filing. Preferably, you hold a PhD or you can document similar solid scientific understanding. You have successfully worked in diverse 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 challenge of international communication.
On a personal level, you like busy and changing circumstances and bring a can-do attitude and a healthy sense of humour even when the pressure is on. You are a strong team player always keeping focus on jointly moving the projects. Still, you are able to work independently, be challenged and find new solutions.
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Contact
For further information, please call Lars Wichmann Madsen +1 609-819-6572 (US East coast time).
Deadline
27 July 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 the department we are a dedicated team of 17 people located in Søborg, Denmark and 6 people currently located in Princeton, USA.
The department covers both products under development and marketed products in the area of inflammation and growth hormone. The department is responsible for interactions with Health Authorities including meetings, submission of clinical trial applications and application for and maintenance of marketing authorisations. We work closely with a diverse range of stakeholders within Novo Nordisk headquarters, our affiliated companies and global Health Authorities.
The Job
The position will be situated in Søborg and you will work in close collaboration with Project Managers, other experienced Regulatory Professionals and Associates. In the team you will be responsible for planning and executing clinical regulatory activities related to your projects. You will plan, coordinate, review and provide sparring in relation to the clinical regulatory documentation. You will also be responsible for preparing and conducting internal meetings and be the point of contact for the clinical development organisation. You will provide clinical regulatory input to strategies, clinical trial applications and meetings with health authorities. You will work closely with the Regulatory Project Manager who is overall responsible for the regulatory input to our projects. Furthermore, you will be part of cross functional teams within Regulatory Affairs. 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 significant regulatory support to clinical phase 3 and filing. Preferably, you hold a PhD or you can document similar solid scientific understanding. You have successfully worked in diverse 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 challenge of international communication.
On a personal level, you like busy and changing circumstances and bring a can-do attitude and a healthy sense of humour even when the pressure is on. You are a strong team player always keeping focus on jointly moving the projects. Still, you are able to work independently, be challenged and find new solutions.
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Contact
For further information, please call Lars Wichmann Madsen +1 609-819-6572 (US East coast time).
Deadline
27 July 2013.