Senior RA Professional
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Søborg
Do you want to be part of a dynamic and exciting organisation? We are committed to obtain Marketing Authorisations for Novo Nordisk’s innovative medicines by regulatory authorities across the globe and we have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.
Apply now for a life-changing career and join us as a Senior Regulatory Professional on CagriSema Obesity!
The position
In this role, you will be required to drive and coordinate several regulatory activities 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.
The department is expanding as the project progresses into multiple indications, late-stage development, and submission. Therefore, we are looking for a candidate with a strong scientific background to become part of the RA team for the filling of one of our high-priority late-stage development projects.
Your tasks will include the following:
• Be part of the non-clinical submission team providing regulatory input and ensuring alignment and implementation of regulatory strategy
• Participate in the development of regulatory documentation for submission to Health Authorities, including regulatory files for marketing authorisation, 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
As a Senior Regulatory Professional, you will report to the Team Leader of RA CagriSema I and take active part in department related activities, including improvement projects across Regulatory Affairs.
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site work in Søborg, Denmark where our team is based.
Qualifications
To be a competitive candidate, you should have:
• A master’s degree within Life Science, Health Science, or a related field
• At least, 4-5 years of experience in Regulatory Affairs or other relevant area in drug development
• Strong IT/digital skills
• 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. Effective communication skills that enable cooperation at all organisational levels are highly valued.
About the department
Regulatory Affairs CagriSema currently consists of 25 dedicated and highly engaged employees. Our department is responsible for the development of global regulatory strategies to advance the project within multiple indications 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 at [email protected].
Deadline
17 December 2023
Please note, we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found.
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.
Apply now for a life-changing career and join us as a Senior Regulatory Professional on CagriSema Obesity!
The position
In this role, you will be required to drive and coordinate several regulatory activities 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.
The department is expanding as the project progresses into multiple indications, late-stage development, and submission. Therefore, we are looking for a candidate with a strong scientific background to become part of the RA team for the filling of one of our high-priority late-stage development projects.
Your tasks will include the following:
• Be part of the non-clinical submission team providing regulatory input and ensuring alignment and implementation of regulatory strategy
• Participate in the development of regulatory documentation for submission to Health Authorities, including regulatory files for marketing authorisation, 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
As a Senior Regulatory Professional, you will report to the Team Leader of RA CagriSema I and take active part in department related activities, including improvement projects across Regulatory Affairs.
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site work in Søborg, Denmark where our team is based.
Qualifications
To be a competitive candidate, you should have:
• A master’s degree within Life Science, Health Science, or a related field
• At least, 4-5 years of experience in Regulatory Affairs or other relevant area in drug development
• Strong IT/digital skills
• 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. Effective communication skills that enable cooperation at all organisational levels are highly valued.
About the department
Regulatory Affairs CagriSema currently consists of 25 dedicated and highly engaged employees. Our department is responsible for the development of global regulatory strategies to advance the project within multiple indications 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 at [email protected].
Deadline
17 December 2023
Please note, we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found.
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 4.12.2023, 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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