Regulatory Professional – CMC
- 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. This makes Regulatory Affairs a truly interesting place to work but also challenging. Are you up for the challenge?
About the department
The RA-Inflammation & Growth Hormone Area is part of Regulatory Affairs and is a dedicated and diverse team of around 25 people. You will work in the CMC department with nine experienced and engaged colleagues working closely with production and quality departments. We are breaking new ground in a dynamic environment, where our dedicated group prepares and executes 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 located in Søborg and you will be part of a team of Regulatory Project Managers, Professionals and Associates. Your role will be to diligently secure the CMC input to global regulatory strategies and submissions for development and LCM projects. You will plan, coordinate and review regulatory documentation and chair internal working groups as our primary sparring partner for the Production and CMC Support units in Novo Nordisk. 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 experience from pharmaceutical Industry working with regulatory aspects of CMC in development or Life Cycle Management projects. You can document solid scientific understanding and 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 contact Bente Brunbakke at +45 3075 7875.
Deadline
1 December 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. This makes Regulatory Affairs a truly interesting place to work but also challenging. Are you up for the challenge?
About the department
The RA-Inflammation & Growth Hormone Area is part of Regulatory Affairs and is a dedicated and diverse team of around 25 people. You will work in the CMC department with nine experienced and engaged colleagues working closely with production and quality departments. We are breaking new ground in a dynamic environment, where our dedicated group prepares and executes 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 located in Søborg and you will be part of a team of Regulatory Project Managers, Professionals and Associates. Your role will be to diligently secure the CMC input to global regulatory strategies and submissions for development and LCM projects. You will plan, coordinate and review regulatory documentation and chair internal working groups as our primary sparring partner for the Production and CMC Support units in Novo Nordisk. 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 experience from pharmaceutical Industry working with regulatory aspects of CMC in development or Life Cycle Management projects. You can document solid scientific understanding and 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 contact Bente Brunbakke at +45 3075 7875.
Deadline
1 December 2013.