Senior Regulatory Project Manager
- 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 is situated in Denmark where you will work in close collaboration with other Project Managers, Regulatory Professionals and Associates. In the team you will be responsible for planning, coordinating and executing regulatory activities. For your projects, you coordinate all aspects of the regulatory affairs discipline and drive regulatory strategies, regulatory submissions and meetings with health authorities. You focus on linking drug development opportunities to regulatory requirements for our innovative projects within autoimmune disease and inflammation. At all times, you seek to secure submission of high quality documentation to health authorities.
You represent Regulatory Affairs in the cross-functional project-team for designated projects. Here, you collaborate closely with all the scientific disciplines to drive the project, ensure regulatory deliverables and make an impact. Together with the Department Directors you contribute to ensuring optimal allocation and use of resources in the departments.
Qualifications
As a minimum, we expect you to have a science university degree plus regulatory project management experience from pharmaceutical development. We expect you have worked on biopharmaceuticals targeting inflammatory conditions and have a proven track record from clinical phase 3 and/or filing. Preferably, you hold a PhD or you can document similar solid scientific understanding. You have successfully headed diverse teams respecting the contribution of everyone. You have demonstrated that you are organised and a proactive problem-solver. You communicate well and are completely comfortable speaking, writing and negotiating in 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 Steven B Johnson +1 609-578-9728 (US East coast time).
Deadline
15 August 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 is situated in Denmark where you will work in close collaboration with other Project Managers, Regulatory Professionals and Associates. In the team you will be responsible for planning, coordinating and executing regulatory activities. For your projects, you coordinate all aspects of the regulatory affairs discipline and drive regulatory strategies, regulatory submissions and meetings with health authorities. You focus on linking drug development opportunities to regulatory requirements for our innovative projects within autoimmune disease and inflammation. At all times, you seek to secure submission of high quality documentation to health authorities.
You represent Regulatory Affairs in the cross-functional project-team for designated projects. Here, you collaborate closely with all the scientific disciplines to drive the project, ensure regulatory deliverables and make an impact. Together with the Department Directors you contribute to ensuring optimal allocation and use of resources in the departments.
Qualifications
As a minimum, we expect you to have a science university degree plus regulatory project management experience from pharmaceutical development. We expect you have worked on biopharmaceuticals targeting inflammatory conditions and have a proven track record from clinical phase 3 and/or filing. Preferably, you hold a PhD or you can document similar solid scientific understanding. You have successfully headed diverse teams respecting the contribution of everyone. You have demonstrated that you are organised and a proactive problem-solver. You communicate well and are completely comfortable speaking, writing and negotiating in 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 Steven B Johnson +1 609-578-9728 (US East coast time).
Deadline
15 August 2013.