Senior Regulatory Affairs Professional for late-stage development project
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Søborg
Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative medicines to patients?
If so, we at Novo Nordisk invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining Marketing Authorisations from regulatory authorities worldwide. We encourage you to apply now and join us in this exciting journey!
The position
As a Senior Regulatory Affairs Professional, you will support the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.
You will entail close collaboration with the Global Regulatory Lead and a team of regulatory professionals, working together towards marketing authorisation and worldwide roll-out. You may be an integral member of cross-functional project teams, including study groups, and submission teams.
Key responsibilities may include:
• Contributing regulatory expertise to global strategies and tactics
• Participating in the development of regulatory documentation for MAA/NDA submission, Q&A with health authorities and approvals.
• Involvement in ongoing clinical trials activities
• Working with regulatory colleagues, project management, medical and non-medical specialists, statisticians, and medical writers, providing regulatory input and contributing to project decisions
• Active involvement in establishing internal positions on regulatory issues, new and changing guidelines, and improvement projects across Regulatory Affairs You will report to the team leader of RA Diabetes Team II and take active part in department related activities. 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 office basedoffice-based work in Søborg, Denmark where our team is based. Qualifications
We expect an ideal candidate to have the following:
• Master's degree within Life Science, Health Science, or a related field
• Several years of regulatory experience in similar position, from the pharmaceutical industry or Health Authority
• Experience of working on projects in late-stage development phase and life-cycle management is an advantage
• Strong IT/digital skills
• Fluency in 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
RA Diabetes is responsible for the development of global regulatory strategies to advance projects within diabetes from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications in close collaboration with our affiliates and global stakeholders. This is an area with about 15 dedicated and highly engaged regulatory leads and professionals organized in 2 teams. 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 Team Leader, Jenny Kastberg at [email protected]. Deadline
21 April 2024. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application. 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.
If so, we at Novo Nordisk invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining Marketing Authorisations from regulatory authorities worldwide. We encourage you to apply now and join us in this exciting journey!
The position
As a Senior Regulatory Affairs Professional, you will support the development of regulatory strategies and executing various regulatory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.
You will entail close collaboration with the Global Regulatory Lead and a team of regulatory professionals, working together towards marketing authorisation and worldwide roll-out. You may be an integral member of cross-functional project teams, including study groups, and submission teams.
Key responsibilities may include:
• Contributing regulatory expertise to global strategies and tactics
• Participating in the development of regulatory documentation for MAA/NDA submission, Q&A with health authorities and approvals.
• Involvement in ongoing clinical trials activities
• Working with regulatory colleagues, project management, medical and non-medical specialists, statisticians, and medical writers, providing regulatory input and contributing to project decisions
• Active involvement in establishing internal positions on regulatory issues, new and changing guidelines, and improvement projects across Regulatory Affairs You will report to the team leader of RA Diabetes Team II and take active part in department related activities. 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 office basedoffice-based work in Søborg, Denmark where our team is based. Qualifications
We expect an ideal candidate to have the following:
• Master's degree within Life Science, Health Science, or a related field
• Several years of regulatory experience in similar position, from the pharmaceutical industry or Health Authority
• Experience of working on projects in late-stage development phase and life-cycle management is an advantage
• Strong IT/digital skills
• Fluency in 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
RA Diabetes is responsible for the development of global regulatory strategies to advance projects within diabetes from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications in close collaboration with our affiliates and global stakeholders. This is an area with about 15 dedicated and highly engaged regulatory leads and professionals organized in 2 teams. 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 Team Leader, Jenny Kastberg at [email protected]. Deadline
21 April 2024. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application. 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 5.4.2024, 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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