Regulatory Professional
- Regulatory Affairs
- Denmark - Søborg
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approvals in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight into the regulatory challenges.
About the department
We are a team of engaged specialists working with development of oral formulations of insulin and GLP-1 analogues.
We are currently looking for a Regulatory Professional with science background combined with regulatory experience to support our activities related to clinical trial submissions and approvals and interactions with health authorities.
The job
In Regulatory Affairs, you’ll work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, project management and the challenges of international communication will be part of your busy workday. You’ll be expected to make an impact, to ask questions and challenge the status quo if that’s what it takes.
As a Regulatory Professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.
You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with variety of stakeholders from different departments in Novo Nordisk. You will participate in review of clinical trial protocols and reports as well as development of regulatory documentation for submission to health authorities, including briefing packages for meetings with health authorities, clinical trial applications, safety reports and finally regulatory file for marketing authorization. You will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions.
Qualifications
We expect you to have a university degree in science (Ph.D degree will be an advantage) and 3-5 years of relevant experience from the pharma industry.
As a person, you thrive in busy environment; bring can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You are flexible and change-oriented person who in challenging situations can see opportunities rather than limitations.
You’re a strong team player, but you are also able to work independently and find new solutions to the challenges you meet. You’re also a skilled communicator who is comfortable speaking and writing in English.
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 contact Vibeke Hatorp on +45 3075 5697.
Deadline
20 December 2013.
- Regulatory Affairs
- Denmark - Søborg
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approvals in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both keen negotiating skills and scientific insight into the regulatory challenges.
About the department
We are a team of engaged specialists working with development of oral formulations of insulin and GLP-1 analogues.
We are currently looking for a Regulatory Professional with science background combined with regulatory experience to support our activities related to clinical trial submissions and approvals and interactions with health authorities.
The job
In Regulatory Affairs, you’ll work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, project management and the challenges of international communication will be part of your busy workday. You’ll be expected to make an impact, to ask questions and challenge the status quo if that’s what it takes.
As a Regulatory Professional you will be required to drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.
You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with variety of stakeholders from different departments in Novo Nordisk. You will participate in review of clinical trial protocols and reports as well as development of regulatory documentation for submission to health authorities, including briefing packages for meetings with health authorities, clinical trial applications, safety reports and finally regulatory file for marketing authorization. You will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions.
Qualifications
We expect you to have a university degree in science (Ph.D degree will be an advantage) and 3-5 years of relevant experience from the pharma industry.
As a person, you thrive in busy environment; bring can-do spirit and a healthy sense of humour to your work – even when the pressure is on. You are flexible and change-oriented person who in challenging situations can see opportunities rather than limitations.
You’re a strong team player, but you are also able to work independently and find new solutions to the challenges you meet. You’re also a skilled communicator who is comfortable speaking and writing in English.
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 contact Vibeke Hatorp on +45 3075 5697.
Deadline
20 December 2013.