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 a truly interesting place to work but also quite challenging. Are you up for the challenge?
About the department
The RA Degludec Clinical Department is situated in the Novo Nordisk project house together with other regulatory functions in Søborg. We are group of 10 highly skilled and dedicated people involved in finalizing the global registration of Tresiba® and Ryzodeg® as well as activities related to Life Cycle Management.
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 keen 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 the worldwide approval and maintenance of Tresiba® and Ryzodeg®.
In collaboration with experienced regulatory professionals and associates you will be responsible for clinical aspects of regulatory affairs activities within the projects.
The job
Responsible for planning, coordination and executing the regulatory tasks as required in the projects or existing products in accordance with the regulatory strategy for the defines area of responsibility. Responsible for preparation and compilation of the individual sections of all files for the defined area of responsibility, in accordance with internal requirements and external regulatory guidelines and regulations
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 and challenge the status quo if that’s what it takes.
You will be a member of a global regulatory team and also work closely with other departments to achieve the ambitious goals of the project.
You will be involved in the planning of and responsible for preparation and maintenance of regulatory documents, the regulatory review of protocols and reports as well as working on worldwide submissions and the following interactions with health authorities. You will also be responsible for keeping up to date with current internal requirements and external guidelines and legislation within area of responsibility. Life cycle management activities will also be a part of the job.
The position has for the right person good development opportunities. Novo Nordisk offers a world of support with first rate professional training, relevant support groups and talented, friendly colleagues.
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 Jane Møll Pedersen at +45 3075 3759 or Dorrit Espersen +45 3075 8242.
Deadline
9 June 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 a truly interesting place to work but also quite challenging. Are you up for the challenge?
About the department
The RA Degludec Clinical Department is situated in the Novo Nordisk project house together with other regulatory functions in Søborg. We are group of 10 highly skilled and dedicated people involved in finalizing the global registration of Tresiba® and Ryzodeg® as well as activities related to Life Cycle Management.
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 keen 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 the worldwide approval and maintenance of Tresiba® and Ryzodeg®.
In collaboration with experienced regulatory professionals and associates you will be responsible for clinical aspects of regulatory affairs activities within the projects.
The job
Responsible for planning, coordination and executing the regulatory tasks as required in the projects or existing products in accordance with the regulatory strategy for the defines area of responsibility. Responsible for preparation and compilation of the individual sections of all files for the defined area of responsibility, in accordance with internal requirements and external regulatory guidelines and regulations
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 and challenge the status quo if that’s what it takes.
You will be a member of a global regulatory team and also work closely with other departments to achieve the ambitious goals of the project.
You will be involved in the planning of and responsible for preparation and maintenance of regulatory documents, the regulatory review of protocols and reports as well as working on worldwide submissions and the following interactions with health authorities. You will also be responsible for keeping up to date with current internal requirements and external guidelines and legislation within area of responsibility. Life cycle management activities will also be a part of the job.
The position has for the right person good development opportunities. Novo Nordisk offers a world of support with first rate professional training, relevant support groups and talented, friendly colleagues.
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 Jane Møll Pedersen at +45 3075 3759 or Dorrit Espersen +45 3075 8242.
Deadline
9 June 2013.