Regulatory Affairs Professional
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Søborg
If you are passionate about drug development within Diabetes and Obesity and want to be a subject matter expert in a leading international organization, then this might be the job for you.
You will have the opportunity to take the lead and set the strategic direction in projects of crucial importance to Novo Nordisk’s growth on a global level.
Apply now for a life-changing career! The position
As a Regulatory Affairs Professional, you will have the opportunity to work within late-stage development, preparing for upcoming MAA/NDA/BLA submissions and roll out in the whole world.
You will be the voice of Regulatory Affairs CMC and you will be responsible for providing scientific and strategic input to the projects you work with to obtain the regulatory approvals. You will turn your knowledge within pharmaceutical operations into regulatory pathways and develop global regulatory CMC strategies based on current legislation and regulations.
You will be in the center of project planning and execution – responsible for planning, coordinating, and reviewing regulatory documentation related to the drug e.g., supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages. More specifically, you will be accountable for: Planning, executing and driving strategic regulatory CMC activities Apply CMC regulatory intelligence to develop robust regulatory strategies Identifying as well as improving regulatory CMC practices, processes and approaches related to regulatory CMC documentation and strategies.
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work preferably in Søborg, Denmark where the global RA CMC & Device department is based. Qualifications
You come with a strong scientific and technical background and mindset, which you have acquired through your experience with RA and/or pharmaceutical operations – manufacturing, product supply, process development, CMC development, analytics, quality assurance and other related areas. The ideal candidate should have: Master’s degree and/or PhD in a relevant field Relevant experience within RA and/or pharmaceutical industry High proficiency in English - written as well as spoken Great communication skills as all work takes place in multidisciplinary project groups.
You are a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, flexibility and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures. About the department
Novo Nordisk Regulatory Affairs CMC & Device makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets. The RA CMC Diabetes and Obesity consist of just over forty-six highly skilled dedicated colleagues with very diverse backgrounds and experience, who are involved in every Regulatory CMC aspect concerning products and projects in these areas. As Novo Nordisk’s product portfolio is growing, we are developing and implementing highly diverse CMC solutions to the complex manufacturing processes, therefore we are looking to expand our team.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are 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, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.
Contact
For more information regarding the role, you are welcome to contact Mette Enghuus Jørgensen (+45-3448 2599). Deadline
12 May 2024 If you are interested in this role, please apply as soon as possible. Applications will be evaluated on an ongoing basis, so there may go some time before you hear from us.
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.
You will have the opportunity to take the lead and set the strategic direction in projects of crucial importance to Novo Nordisk’s growth on a global level.
Apply now for a life-changing career! The position
As a Regulatory Affairs Professional, you will have the opportunity to work within late-stage development, preparing for upcoming MAA/NDA/BLA submissions and roll out in the whole world.
You will be the voice of Regulatory Affairs CMC and you will be responsible for providing scientific and strategic input to the projects you work with to obtain the regulatory approvals. You will turn your knowledge within pharmaceutical operations into regulatory pathways and develop global regulatory CMC strategies based on current legislation and regulations.
You will be in the center of project planning and execution – responsible for planning, coordinating, and reviewing regulatory documentation related to the drug e.g., supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages. More specifically, you will be accountable for:
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office and on-site work preferably in Søborg, Denmark where the global RA CMC & Device department is based. Qualifications
You come with a strong scientific and technical background and mindset, which you have acquired through your experience with RA and/or pharmaceutical operations – manufacturing, product supply, process development, CMC development, analytics, quality assurance and other related areas. The ideal candidate should have:
You are a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, flexibility and integrity. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures. About the department
Novo Nordisk Regulatory Affairs CMC & Device makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets. The RA CMC Diabetes and Obesity consist of just over forty-six highly skilled dedicated colleagues with very diverse backgrounds and experience, who are involved in every Regulatory CMC aspect concerning products and projects in these areas. As Novo Nordisk’s product portfolio is growing, we are developing and implementing highly diverse CMC solutions to the complex manufacturing processes, therefore we are looking to expand our team.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are 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, through to manufacturing, marketing, and sales – we are all working to move the needle on patient care.
Contact
For more information regarding the role, you are welcome to contact Mette Enghuus Jørgensen (+45-3448 2599). Deadline
12 May 2024 If you are interested in this role, please apply as soon as possible. Applications will be evaluated on an ongoing basis, so there may go some time before you hear from us.
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 26.4.2024, 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
Lignende jobs
-
Director, Global Regulatory Affairs - CMC
At [xxxxx], we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and th..Få mere info- Apoteker
- København
-
Regulatory Affairs Specialist
Cerebriu, an award-winning health-tech startup, is at the forefront of revolutionizing the field of radiology through cutting-edge AI software. Our real-time interpretation of brain MRI images enab..Få mere info- Apoteker
- København
-
Senior Manager, Global Regulatory Affairs Operatio...
At [xxxxx], we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and th..Få mere info- Apoteker
- København
-
Executive Management Assistant at Xellia Pharmaceu...
Are you ready to make a difference and play a crucial role in an organization dedicated to saving lives? Are you the person who cares about making your executives everyday life work, and have you d..Få mere info- Apoteker
- København
Statistik over udbudte jobs som apotekere i Søborg
Herunder ser du udviklingen i udbudte apoteker 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 apotekere.
Se flere statistikker her:
Statistik over udbudte apotekere i Søborg over tid
| Dato | Alle jobs som apotekere |
|---|---|
| 4. november 2024 | 2 |
| 3. november 2024 | 3 |
| 2. november 2024 | 3 |
| 1. november 2024 | 4 |
| 31. oktober 2024 | 4 |
| 30. oktober 2024 | 3 |
| 29. oktober 2024 | 3 |
| 28. oktober 2024 | 2 |
| 27. oktober 2024 | 3 |
| 26. oktober 2024 | 3 |
| 25. oktober 2024 | 3 |
| 24. oktober 2024 | 3 |
| 23. oktober 2024 | 3 |
| 22. oktober 2024 | 4 |
| 21. oktober 2024 | 4 |
| 20. oktober 2024 | 5 |
| 19. oktober 2024 | 5 |
| 18. oktober 2024 | 5 |
| 17. oktober 2024 | 4 |
| 16. oktober 2024 | 4 |
| 15. oktober 2024 | 4 |
| 14. oktober 2024 | 3 |
| 13. oktober 2024 | 6 |
| 12. oktober 2024 | 5 |
| 11. oktober 2024 | 4 |
| 10. oktober 2024 | 4 |
| 9. oktober 2024 | 4 |
| 8. oktober 2024 | 4 |
| 7. oktober 2024 | 4 |
| 6. oktober 2024 | 4 |
| 5. oktober 2024 | 4 |