Senior Regulatory Professional - RA New Generation Insulin Projects

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

Søborg

  • Regulatory
  • Søborg

Join Regulatory Affairs and become part of an exciting environment where engaged people are committed to gain approval of Novo Nordisk’s medicines by regulatory authorities across the globe. Our people 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 New Generation Insulin Projects are regulatory responsible for the clinical new generation insulin development projects as well as the clinical Life Cycle Management activities for marketed long-acting (Tresiba®), fixed combination (Ryzodeg®, Xultophy®), and fast-acting (Fiasp®) insulin products. We are 16 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 Senior Regulatory Professional with a strong scientific background and a genuine interest in being part of the future within New Generation Insulin Projects.

The job

As a 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 teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments and affiliates in Novo Nordisk. You will participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory files for marketing authorisation. Furthermore, you will be expected to provide regulatory input, be proactive, challenge the discussions and contribute to project team decisions. You will among others interact with 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.

Qualifications

We expect you to have a master degree in life science (preferably complemented by a PhD) and 4-7 years of experience from the pharma industry (e.g. regulatory sciences, clinical and non-clinical drug development, device development, medical writing, clinical trial management). As a person you thrive in a busy environment; bring a can-do spirit and a healthy sense of humour to your work. You are a flexible and change-oriented person who focus on opportunities rather than limitations in challenging situations.

Working at Novo Nordisk

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Contact

For further information, please contact Louise Buchholt Johansen on +45 3079 13 81.

Deadline

Deadline 28 January 2020. Relevant candidates will be invited for interview also before deadline.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


Information og data

Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 16.1.2020, 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.
  • Afdelingsleder
  • Søborg

Lignende jobs

  • Erfaren afdelingsleder med empati og overblik til ...

    Fri kontakt
    Erfaren afdelingsleder med empati og overblik til Tunegrupperne Tune Skole. Drømmer du om at bruge din ledelseserfaring på en skole, der emmer af engagement og lys i øjnene? Kan du se dig selv som leder af vores specialafdeling, og er du en leder, der har masser af tillid til dine medarbejdere?
    • Afdelingsleder
    • Greve
    Få mere info
  • Projektleder til udvikling og etablering af Mosede...

    Fri kontakt
    KLAR Forsyning er gået i gang med en gennemgribende renovering af Mosede Renseanlæg, der ligger i midten af et parcelhuskvarter. Det har givet mulighed for at overdække tankene og åbne området op for offentlig adgang.
    • Afdelingsleder
    • Greve
    Få mere info
  • Projektleder/Udbudskonsulent i Greve Kommune

    Fri kontakt
    Indkøb og Udbud søger en engageret og løsningsorienteret Udbudskonsulent, som kan drive og udvikle udbudsprocesser på tværs af hele kommunen. I Greve Kommune får du mulighed for at arbejde tæt sammen med forskellige fagcentre, hvor du vil opleve et spændende og varieret udbudslandskab.
    • Afdelingsleder
    • Greve
    Få mere info
  • Head of Regional Category Management - Europe

    Opportunity Head of Regional Category Management - Europe Are you ready to embark on an exciting career journey in the dynamic world of terminal operations? APM Terminals is a global expert i..
    • Afdelingsleder
    • København K
    Få mere info

Statistik over udbudte jobs som afdelingsleder i Søborg

Herunder ser du udviklingen i udbudte afdelingsleder 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 afdelingsleder.

Se flere statistikker her:
Statistik over udbudte afdelingsleder i Søborg over tid

Dato Alle jobs som afdelingsleder
23. november 2024 5
22. november 2024 5
21. november 2024 4
20. november 2024 4
19. november 2024 4
18. november 2024 4
17. november 2024 4
16. november 2024 4
15. november 2024 4
14. november 2024 3
13. november 2024 3
12. november 2024 3
11. november 2024 2
10. november 2024 2
9. november 2024 2
8. november 2024 2
7. november 2024 3
6. november 2024 2
5. november 2024 2
4. november 2024 2
3. november 2024 2
2. november 2024 2
1. november 2024 2
31. oktober 2024 3
30. oktober 2024 4
29. oktober 2024 5
28. oktober 2024 5
27. oktober 2024 5
26. oktober 2024 5
25. oktober 2024 2
24. oktober 2024 5