Regulatory Project Coordinator
- Regulatory Affairs
- Denmark - Søborg
Do you have the drive and ambition it takes to beat even the toughest challenge? Then join our fast-changing environment where we do our best to get Novo Nordisk’s medicines approved across the globe. We are a diverse team where we use our unique combination of scientific insight and our ability to navigate many agendas and stakeholders. This makes Regulatory Affairs a challenging yet truly interesting and fast-paced place to work.
About the department
RA CMC Insulin & Oral Proteins is a dedicated and diverse department of 30 competent people responsible for obtaining and maintaining marketing authorisations worldwide. We work closely together with numerous stakeholders both within Novo Nordisk headquarters and affiliates throughout the world. The department is responsible for life cycle management activities on our insulin products including manufacturing site approvals as well as the regulatory CMC aspects of early development projects within Oral Proteins.
The job
As Regulatory Project Coordinator with focus on supply flexibility, you will be part of a small team of colleagues supporting the insulin supply strategies and working towards ensuring fast regulatory approvals of our manufacturing sites globally. You will have an important role in developing the regulatory tactical and strategic input for supply strategies for new and existing factories, to optimise Novo Nordisk’s global manufacturing network by navigating the challangespartaining to regulatory complexity.
Stakeholder management and collaboration, project management and the challenges of international communication will be part of your everyday worklife. You will collaborate with Supply Chain Planning, communicate closely with key affiliates to follow up on targets and facilitate alignment between Product Supply and Regulatory Affairs. The responsibility for clarifying regulatory requirements and challenging the common practice is yours, and in collaboration with affiliate colleagues you will develop plans for fast submission and approval.
You interpersonal skills will be challenged daily when working across teams within the department as well as with other areas of RA in an international context. You will become experienced with current and future supply and demand challenges and obtain understanding of how to ensure supply flexibility from a regulatory point. To be a success you will have to make a significant difference in improving the way we ensure regulatory flexibility in support of our growing manufacturing network.
Qualifications
You hold a master’s degree within business and/or science and a proven track record and professional experience working with stakeholder management, coordination and preferably supply chain management or regulatory affairs from an international perspective.
You have drive and a “can do” attitude combined with the desire to be a strong teamplayer and an ability to work independently. You see opportunities for improvements, find new solutions to the challenges and can in a convincingly way convey the message.
Taking ownership of your tasks comes naturally to you and you are capeable of managing a high number of tasks in an everchanging environment. You thrive in a busy environment and carry a positive mindset despite a high workload. In addition, we offer an informal atmosphere with ample space for humor and good opportunities for individual development.
You write and speak English fluently.
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 Jens Bjørn Nielsen, +45 3075 6120.
Deadline
1 December 2013.
- Regulatory Affairs
- Denmark - Søborg
Do you have the drive and ambition it takes to beat even the toughest challenge? Then join our fast-changing environment where we do our best to get Novo Nordisk’s medicines approved across the globe. We are a diverse team where we use our unique combination of scientific insight and our ability to navigate many agendas and stakeholders. This makes Regulatory Affairs a challenging yet truly interesting and fast-paced place to work.
About the department
RA CMC Insulin & Oral Proteins is a dedicated and diverse department of 30 competent people responsible for obtaining and maintaining marketing authorisations worldwide. We work closely together with numerous stakeholders both within Novo Nordisk headquarters and affiliates throughout the world. The department is responsible for life cycle management activities on our insulin products including manufacturing site approvals as well as the regulatory CMC aspects of early development projects within Oral Proteins.
The job
As Regulatory Project Coordinator with focus on supply flexibility, you will be part of a small team of colleagues supporting the insulin supply strategies and working towards ensuring fast regulatory approvals of our manufacturing sites globally. You will have an important role in developing the regulatory tactical and strategic input for supply strategies for new and existing factories, to optimise Novo Nordisk’s global manufacturing network by navigating the challangespartaining to regulatory complexity.
Stakeholder management and collaboration, project management and the challenges of international communication will be part of your everyday worklife. You will collaborate with Supply Chain Planning, communicate closely with key affiliates to follow up on targets and facilitate alignment between Product Supply and Regulatory Affairs. The responsibility for clarifying regulatory requirements and challenging the common practice is yours, and in collaboration with affiliate colleagues you will develop plans for fast submission and approval.
You interpersonal skills will be challenged daily when working across teams within the department as well as with other areas of RA in an international context. You will become experienced with current and future supply and demand challenges and obtain understanding of how to ensure supply flexibility from a regulatory point. To be a success you will have to make a significant difference in improving the way we ensure regulatory flexibility in support of our growing manufacturing network.
Qualifications
You hold a master’s degree within business and/or science and a proven track record and professional experience working with stakeholder management, coordination and preferably supply chain management or regulatory affairs from an international perspective.
You have drive and a “can do” attitude combined with the desire to be a strong teamplayer and an ability to work independently. You see opportunities for improvements, find new solutions to the challenges and can in a convincingly way convey the message.
Taking ownership of your tasks comes naturally to you and you are capeable of managing a high number of tasks in an everchanging environment. You thrive in a busy environment and carry a positive mindset despite a high workload. In addition, we offer an informal atmosphere with ample space for humor and good opportunities for individual development.
You write and speak English fluently.
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 Jens Bjørn Nielsen, +45 3075 6120.
Deadline
1 December 2013.