Senior Regulatory Professional
- Regulatory Affairs
- Denmark - Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine 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 (RA) a truly interesting place to work but also quite challenging.
About the department
The RA IDegLira Clinical Department is located in the Novo Nordisk project house in Søborg. We are group of 7 highly skilled and dedicated people involved in development of both early and late stage development projects.
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world and make a meaningful difference to our business.
We are currently looking for a Senior Regulatory Professional with a science background combined with regulatory experience to join our team responsible for two diabetes development projects.
In collaboration with experienced regulatory professionals and associates you will be responsible for clinical and preferably also non-clinical aspects of regulatory affairs activities within the projects.
The job
In Regulatory Affairs, you’ll work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, 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 Senior 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 a 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, regulatory files for marketing authorization and initiate Life Cycle Management activities. 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 life sciences and documented professional experience working with regulatory affairs and/or the pharma industry. Project management experience is a plus, but not required. You are organised, a good planner and a proactive problem-solver, and you’re a skilled communicator who is comfortable speaking and writing in English.
As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work even when the pressure’s on. You’re a strong team player, but you also enjoy working independently.
At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
We create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.
Contact
For further information, please contact Marianne Bork Samuelsen at +45 3079 6941 or Hanne Aae Theilgaard +45 3075 0015.
Deadline
15 December 2013.
- Regulatory Affairs
- Denmark - Søborg
Join a fast-changing environment where engaged people do their best every day to get Novo Nordisk medicine 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 (RA) a truly interesting place to work but also quite challenging.
About the department
The RA IDegLira Clinical Department is located in the Novo Nordisk project house in Søborg. We are group of 7 highly skilled and dedicated people involved in development of both early and late stage development projects.
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the dedicated employees in our unit need both negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world and make a meaningful difference to our business.
We are currently looking for a Senior Regulatory Professional with a science background combined with regulatory experience to join our team responsible for two diabetes development projects.
In collaboration with experienced regulatory professionals and associates you will be responsible for clinical and preferably also non-clinical aspects of regulatory affairs activities within the projects.
The job
In Regulatory Affairs, you’ll work in a fast-paced environment where no two days are alike. Tight deadlines, cross-departmental collaboration, 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 Senior 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 a 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, regulatory files for marketing authorization and initiate Life Cycle Management activities. 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 life sciences and documented professional experience working with regulatory affairs and/or the pharma industry. Project management experience is a plus, but not required. You are organised, a good planner and a proactive problem-solver, and you’re a skilled communicator who is comfortable speaking and writing in English.
As a person, you thrive in busy environments and bring a can-do spirit and a healthy sense of humour to your work even when the pressure’s on. You’re a strong team player, but you also enjoy working independently.
At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
We create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference.
Contact
For further information, please contact Marianne Bork Samuelsen at +45 3079 6941 or Hanne Aae Theilgaard +45 3075 0015.
Deadline
15 December 2013.