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Join Regulatory Affairs and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe. 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.
About the department
RA Diabetes & Obesity is responsible for the regulatory deliverables for clinical projects and life cycle management activities for diabetes and obesity products. We are a team of dedicated and highly engaged employees working in the department. We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams.
We are currently looking for a Regulatory Affairs Specialist with a strong scientific background and a genuine interest in being part of the future within diabetes and obesity.
The job
As a Regulatory Affairs Specialist you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be working closely with Global Regulatory Lead during a process of worldwide submissions and approvals of new medicinal product. Specifically, you will have a critical responsibility in approval process of a new drug, where you will lead cross-functional teams toward forming strategies and responding questions to major Health Authorities, and by that, securing progress toward regulatory approvals.
You will be involved in critical strategic discussions in the project, where you will be expected to contribute to regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to business-critical decisions.
You will, among others, interact with project management, medical and non-clinical specialists, statisticians and medical writers. You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes across the organisation.
As a regulatory specialist you will be expected to contribute to developing younger colleagues, sharing your knowledge and experience and contribute to high performance of the regulatory project team.
You will report to the Regulatory Affairs Director
Qualifications
We expect you have a Master of Science degree (life sciences) with 6-8 years relevant experience and/or PhD with 4-5 years of relevant working experience. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical area. You have experience interacting directly with regulatory authorities on an international scale. You have strong negotiation skills and a sound business understanding. You also know how to set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues.
As a person you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can work at any organisational level. Finally, you are comfortable using your fluent written and spoken English.
Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication, and ambition to help people with chronic diseases such as Diabetes, Obesity, NASH, CVD/CKD, Rare Endocrine Disorders, and Rare Blood Disorders. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development.
Contact
For further information, please contact Magdalena Jayatissa + 45 30 79 49 42
Deadline
Deadline 10 November 2022.
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.
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About the department
RA Diabetes & Obesity is responsible for the regulatory deliverables for clinical projects and life cycle management activities for diabetes and obesity products. We are a team of dedicated and highly engaged employees working in the department. We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams.
We are currently looking for a Regulatory Affairs Specialist with a strong scientific background and a genuine interest in being part of the future within diabetes and obesity.
The job
As a Regulatory Affairs Specialist you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be working closely with Global Regulatory Lead during a process of worldwide submissions and approvals of new medicinal product. Specifically, you will have a critical responsibility in approval process of a new drug, where you will lead cross-functional teams toward forming strategies and responding questions to major Health Authorities, and by that, securing progress toward regulatory approvals.
You will be involved in critical strategic discussions in the project, where you will be expected to contribute to regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to business-critical decisions.
You will, among others, interact with project management, medical and non-clinical specialists, statisticians and medical writers. You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes across the organisation.
As a regulatory specialist you will be expected to contribute to developing younger colleagues, sharing your knowledge and experience and contribute to high performance of the regulatory project team.
You will report to the Regulatory Affairs Director
Qualifications
We expect you have a Master of Science degree (life sciences) with 6-8 years relevant experience and/or PhD with 4-5 years of relevant working experience. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical or clinical area. You have experience interacting directly with regulatory authorities on an international scale. You have strong negotiation skills and a sound business understanding. You also know how to set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues.
As a person you are well-organised and have solid problem-solving capabilities, just as you show a winning attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can work at any organisational level. Finally, you are comfortable using your fluent written and spoken English.
Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication, and ambition to help people with chronic diseases such as Diabetes, Obesity, NASH, CVD/CKD, Rare Endocrine Disorders, and Rare Blood Disorders. We offer the chance to be part of a truly global and highly diverse workplace, where passion and engagement are met with opportunities for professional and personal development.
Contact
For further information, please contact Magdalena Jayatissa + 45 30 79 49 42
Deadline
Deadline 10 November 2022.
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.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 4.11.2022, 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.
- Øvrige
- Søborg
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Statistik over udbudte jobs som øvrige i Søborg
Herunder ser du udviklingen i udbudte øvrige i Søborg over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige.
Se flere statistikker her:
Statistik over udbudte øvrige i Søborg over tid
| Dato | Alle jobs som øvrige |
|---|---|
| 13. november 2024 | 65 |
| 12. november 2024 | 61 |
| 11. november 2024 | 58 |
| 10. november 2024 | 60 |
| 9. november 2024 | 60 |
| 8. november 2024 | 59 |
| 7. november 2024 | 60 |
| 6. november 2024 | 58 |
| 5. november 2024 | 56 |
| 4. november 2024 | 55 |
| 3. november 2024 | 57 |
| 2. november 2024 | 57 |
| 1. november 2024 | 57 |
| 31. oktober 2024 | 55 |
| 30. oktober 2024 | 56 |
| 29. oktober 2024 | 56 |
| 28. oktober 2024 | 56 |
| 27. oktober 2024 | 56 |
| 26. oktober 2024 | 56 |
| 25. oktober 2024 | 52 |
| 24. oktober 2024 | 56 |
| 23. oktober 2024 | 55 |
| 22. oktober 2024 | 58 |
| 21. oktober 2024 | 59 |
| 20. oktober 2024 | 60 |
| 19. oktober 2024 | 61 |
| 18. oktober 2024 | 62 |
| 17. oktober 2024 | 65 |
| 16. oktober 2024 | 66 |
| 15. oktober 2024 | 68 |
| 14. oktober 2024 | 65 |