Senior Regulatory Professional

Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger

Søborg

Would you like to be part of a team working on a project in phase 3 within a rare disease that soon will face an exciting period of authority interactions and planning for marketing authorisation on a global scale? Do you want to be responsible for driving several regulatory tasks in a cross functional project and submission team and to interact with a variety of stakeholders in Novo Nordisk. Apply today and join us in Regulatory Affairs in Søborg for a life-changing career. The position As our new Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. You will be a member of cross functional project and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk such as project management, medical and non-clinical specialists, statisticians, and medical writers. Among other things, you will be responsible for the development of regulatory documentation for submission to Health Authorities including response packages, clinical trial applications, paediatric investigation plans, labelling, and regulatory files for marketing authorisation. Specifically for this job, you will get the opportunity to be part of a team working on a project in phase 3 within a rare disease that soon will be facing a very exciting period of authority interactions and planning for marketing authorisation. You will report to the Associate Director of RA or Haemoglobinopathies and Early Development and take active part in department-related activities, including improvement projects across RA. Qualifications To succeed in this role, we expect you to have a university degree in life science and 4-5 years of regulatory or drug development experience. As a person you thrive in a fast-paced work environment with unfamiliar situations. You bring a can-do spirit and are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. You are a skilled communicator who can collaborate as a strategic business partner at any organizational level. Finally, you are comfortable using your fluent written and spoken English. About the department In Regulatory Affairs (RA) Haemoglobinopathies and Early Development we contribute to the development of treatments within Rare Blood Disorders with a pipeline including a variety of different modalities and technologies. We are a team of 7 dedicated and highly engaged employees with diverse background and experience. We value trust & openness and work in an environment where sharing of knowledge, new ideas, and innovative approaches to regulatory strategy and tactics are highly appreciated. We are an integrated part of the global development, research project teams and cross-functional sub-teams. We are responsible for the regulatory strategies and tactics and provide regulatory expertise to the product development plan. We drive product labelling, Health Authority interactions and clinical trial applications. We have a strong collaboration with our stakeholders in affiliates and work in global regulatory matrix teams with colleagues from RA CMC, RA device, US etc., who all have important roles and contributions, and together form a team with the capacity to execute ambitions plans. 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 letting perfection standing in the way of good. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Marie Aavang Geist at +45 3448 0290. Deadline 12 March 2023. We shall conduct interviews on an ongoing basis, so please submit your application as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 20.2.2023, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Søborg
Rapportér

Lignende jobs

  • Øvrige i København Ø

    Fri kontakt
    Senior Associates og Managere til Transaction Advisory Service i København. Vi mærker en stigende efterspørgsel efter rådgivning i forbindelse med køb og salg af virksomheder, herunder finansiel due diligence. Derfor søger vi Senior Associates og Managere til vores TAS team på Østerbro.
    • Øvrige
    • København Ø
    Få mere info

  • Øvrige i København K

    Fri kontakt
    Associate til IT Risk Assurance. Vi vækster i Grant Thorntons IT Risk Assurance & Advisory Services, og søger derfor en nyuddannet kollega. I afdelingen beskæftiger vi os med IT-revision, afgivelse af IT-erklæringer (ISAE 3402, ISAE 3000 mv.
    • Øvrige
    • København K
    Få mere info

  • Øvrige i København

    Fri kontakt
    Ansøg senest: 19. juni 2024 København On-site. Er du ambitiøs, målrettet og ikke bange for at rydde vanetænkning af bordet, så tror vi på, at du er vores nye Assisterende Restaurant Manager på Scandic Kødbyen.
    • Øvrige
    • København
    Få mere info

  • Øvrige (studiejob) i København K

    Fri kontakt
    Studentermedhjælper til Procesafdelingen. Kan du være med til at effektivisere og digitalisere vores interne arbejdsgange, og være med til at bygge broer med bæredygtige løsninger - ganske enkelt sørge for at alle medarbejdere har de bedste betingelser for at levere deres ydelser?
    • Øvrige
    • København K
    Få mere info

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 over tid

Dato Alle jobs som øvrige
14. juni 2024 71
13. juni 2024 68
12. juni 2024 64
11. juni 2024 65
10. juni 2024 63
9. juni 2024 66
8. juni 2024 66
7. juni 2024 63
6. juni 2024 59
5. juni 2024 55
4. juni 2024 55
3. juni 2024 55
2. juni 2024 57
1. juni 2024 60
31. maj 2024 63
30. maj 2024 62
29. maj 2024 58
28. maj 2024 60
27. maj 2024 60
26. maj 2024 61
25. maj 2024 61
24. maj 2024 60
23. maj 2024 66
22. maj 2024 66
21. maj 2024 70
20. maj 2024 69
19. maj 2024 70
18. maj 2024 70
17. maj 2024 73
16. maj 2024 73
15. maj 2024 74
Fold ud

Populære søgninger

Lignende søgeresultater

Se alle populære søgninger