Senior Regulatory Professional
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Are you passionate about obtaining Marketing Authorisations for innovative medicines? Do you thrive in a dynamic and challenging environment? Join us as a Senior Regulatory Professional in Global Regulatory Affairs and be part of a team committed to making a difference in the lives of patients worldwide. If you are ready for a life-changing opportunity, apply now! The position
As a Senior Regulatory Professional, you will play a crucial role in the development and execution of regulatory strategies. This will entail close collaboration with the Global Regulatory Lead working together to advance a Phase II project. You will drive and coordinate several regulatory activities with challenging and often overlapping timelines and be a member of cross functional project teams including study groups, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. Your tasks will include the following: Contribute with regulatory expertise to global strategies and tactics Participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports Provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions Interact with medical and non-clinical specialists, statisticians, and medical writers You will report to the Team Leader of RA CagriSema Obesity & Amylin and actively participate in department-related activities, including improvement projects across Regulatory Affairs. Qualifications
We expect you to have: Master's degree within Life Science, Health Science, or a related field At least 5-6 years of experience in Regulatory Affairs or other relevant area in drug development Strong IT/digital skills Possess effective communication, that enable cooperation at all organisational levels Fluent written and spoken English Personally, you thrive in team environments and actively contribute to their team's success. You should be well-organised, possess robust problem-solving capabilities, and maintain a strategic focus. A positive, can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humour under pressure. About the department
RA CagriSema Obesity & Amylin currently consists of 14 dedicated and highly engaged employees. Our department is responsible for the development of global regulatory strategies to advance the project from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications. We work as an integrated part of the global development organisation and play a key role in the cross-functional teams. We are responsible for the development, implementation and execution of global regulatory strategies and regulatory operational activities in alignment with the global project development plan. We drive label development, health authority interactions and regulatory submissions, hereunder initial marketing authorisation applications, paediatric plans, and clinical trial applications. We have a close collaboration with our affiliates and global stakeholders. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Christina Winther Poulsen, Regulatory Affairs Team Leader at [email protected]. Deadline
18 February 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
As a Senior Regulatory Professional, you will play a crucial role in the development and execution of regulatory strategies. This will entail close collaboration with the Global Regulatory Lead working together to advance a Phase II project. You will drive and coordinate several regulatory activities with challenging and often overlapping timelines and be a member of cross functional project teams including study groups, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk. Your tasks will include the following:
We expect you to have:
RA CagriSema Obesity & Amylin currently consists of 14 dedicated and highly engaged employees. Our department is responsible for the development of global regulatory strategies to advance the project from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications. We work as an integrated part of the global development organisation and play a key role in the cross-functional teams. We are responsible for the development, implementation and execution of global regulatory strategies and regulatory operational activities in alignment with the global project development plan. We drive label development, health authority interactions and regulatory submissions, hereunder initial marketing authorisation applications, paediatric plans, and clinical trial applications. We have a close collaboration with our affiliates and global stakeholders. Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Christina Winther Poulsen, Regulatory Affairs Team Leader at [email protected]. Deadline
18 February 2024. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 5.2.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg
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