Senior Regulatory Professional for cross-functional Projects - Biopharm

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

Søborg

  • Regulatory
  • Søborg

Do you have a strong regulatory scientific background? How about participating in creation of NDAs/MAAs for novel strategy submissions with global impact?

Join ‘Regulatory Affairs’ as our new Senior Regulatory Professional within Haemophilia projects and be part of a team of engaged people doing their best every day to get Novo Nordisk’s medicines approved across the globe?

About the department

RA Haemophilia is responsible for the regulatory deliverables for clinical projects as well as life cycle managements of approved products.

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, clinical trial applications and global submission strategies. We have a strong collaboration with our affiliates and work in global regulatory teams.

In RA Haemophilia we are 14 dedicated and highly engaged employees. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. . We work as an integrated part of the global development and research project teams and cross-functional sub-teams.

All of this makes Regulatory Affairs a truly interesting place to work in a fast-changing environment.

About the job

As a Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with a high degree of complexity. 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 in Novo Nordisk.

You will be responsible for the development of regulatory documentation for submission to Health Authorities, including regulatory file for marketing authorisation globally (BLA/MAA), responses to questions from Health Authorities, briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports etc.

Furthermore, you will contribute to the global regulatory strategies and tactics, project team decisions, improvement and maintenance of regulatory processes across the organisation.

Qualifications

We expect you to have a master’s degree in science and minimum 5-7 years of experience from working in Regulatory Affairs within Pharma.

You have a thorough understanding of regulatory requirements and guidelines and you have experience from working with clinical regulatory activities in development projects.

Preferably you have experience from preparation and submission of a BLA/MAA globally. Experience with rare diseases is an advantage.

You have a flair for IT systems and experience with MS Office applications. Fluency in written and spoken English is a must.

On a personal level, you have good communication, project management and negotiation skills as you will interact with project management, medical and non-clinical specialists, trial managers, statisticians and medical writers.

You combine your ability to understand technical and operational challenges with a strategic mindset. You work according to high ethical standards, a strong quality mind-set and with the patient in mind.

Contact

For further information, please call Jane Møll Pedersen at +45 30753759

Deadline

March 29th 2020

Please note that we screen applications daily and invite candidates for interviews 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 5.2.2020, 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

  • STU Greve leder efter en kollega til vores Design ...

    Fri kontakt
    Særligt Tilrettelagt Ungdomsuddannelse i Greve er et tilbud for unge med generelle indlæringsvanskeligheder, udviklingsforstyrrelse inden for autismespektret, ADHD og andet. Fælles for målgruppen er, at de alle har brug for et specialiseret uddannelsestilbud. Tilbuddet rummer op til 55 unge i aldersgruppen 16-25 år.
    • Afdelingsleder
    • Greve
    Få mere info
  • Leder af hjemmeplejensygeplejen i Greve Kommune

    Fri kontakt
    Bliv Leder af Hjemmesygeplejen i Greve Kommune – skab fremtidens helhedspleje sammen med os. Er du en passioneret leder med erfaring inden for sygepleje, der trives med at skabe resultater gennem andre? Trives du i af at navigere i en tid præget af udvikling og reformer som skaber usikkerhed og kalder på nye løsninger?
    • Afdelingsleder
    • Greve
    Få mere info
  • 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
  • Faglig stærk mellemleder pr. 1. januar 2025 til ve...

    Fri kontakt
    Holmebo ligger i Greves smørhul, tæt på strand, grønne arealer, læringsrige legepladser, skoler og offentlige transportmidler. Holmebo er normeret til 45 vuggestuebørn, 68 børnehavebørn samt 6 basisbørn. Vi er en glad personalegruppe, som værner om hinanden og den positive arbejdsplads. Husets værdier er bla.
    • Afdelingsleder
    • Greve
    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
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
23. oktober 2024 5
22. oktober 2024 5
21. oktober 2024 5
20. oktober 2024 5
19. oktober 2024 5
18. oktober 2024 5
17. oktober 2024 5
16. oktober 2024 5
15. oktober 2024 5
14. oktober 2024 5
13. oktober 2024 6
12. oktober 2024 6
11. oktober 2024 6
10. oktober 2024 6