Regulatory Specialist - RA Oral Peptide & CVD Projects

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

Søborg

  • Regulatory
  • Søborg

Join Regulatory Affairs (RA) 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. 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 Oral Peptide & Cardiovascular Disease (CVD) Projects are responsible for development projects within the innovative new delivery technology that brings peptides in tablets available to patients or development projects for cardiovascular diseases. We are eight 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 strategy 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 Specialist with a scientific background combined with extensive regulatory and drug development experience to take on the role as Global Regulatory Lead (GRL) for diabetes and/or CVD projects in early or late phase of development and be responsible for the global regulatory strategy.

The job

As Regulatory Specialist/GRL you will be responsible for the project plan and project execution, provide regulatory input for the project strategy, interact with internal and external stakeholders (e.g. Health Authorities) and represent Regulatory Affairs in project core teams/global project teams. Here, you ensure regulatory deliverables according to agreed timelines, cost and quality. You will assume the role of the challenger who makes an impact, seeks solutions and drive innovations.

Furthermore, you will lead global regulatory teams being responsible for regulatory activities for diabetes or CVD projects. As a Regulatory Specialist/GRL, you will be overall responsible for submission and approval of clinical trial applications, for driving and coordinating preparation of meeting packages to Health Authorities, conduct Health Authority interactions and for regulatory submissions and approvals. You will interact with medical specialists, researchers and regulators. All in all, you will have a large responsibility and you will have a lot of influence and impact on the way we reach our goals.

You will report to the Director of RA Oral Peptide & CVD Projects and take active part in department related activities, including improvement projects across RA.

Qualifications

Your background covers an MSc within Biology or Health Science and a relevant PhD or similar documented scientific qualifications. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical and clinical area. You have experience interacting directly with regulatory authorities on an international scale. You have proven 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 loose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can cooperate at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis.

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 Vibeke Hatorp at +45 3075 5697.

Deadline

31 December 2019.

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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 18.12.2019, 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
  • Tirsdag den 31. december 2019
Rapportér

Lignende jobs

  • Senior Associates og Managers til Transaction Advi...

    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

  • Lydtekniker, fuldtid, Scandic Falkoner

    Fri kontakt
    Er du ambitiøs, målrettet og ikke bange for at bryde vanetænkning, så tror vi på, at du er vores nye lydtekniker på Scandic Falkoner i København. Vi ved, at du brænder for alt det tekniske, og er professionel i lydteknik.
    • Øvrige
    • København
    Få mere info

  • Bar Supervisor, full-time, Cube Bar - Scandic Webe...

    Fri kontakt
    Job Description. Can you stay calm and collected, even when the bar is full to bursting, and make sure every cocktail is served with respect for the delicious ingredients? Then we believe you could be our new Bar Supervisor at Cube Bar at Scandic Webers.
    • Øvrige
    • København
    Få mere info

  • Vikarstilling: barselsvikar planlægger

    Fri kontakt
    Attraktivt barselsvikariat som planlægger til hjemmeplejen Greve. Vores område i Greve har brug for en barselsvikar for vores ene planlægger. Er du SSA eller sygeplejerske og vil du være med til at præge opgaveløsningen, så vores borgere får den bedste pleje og omsorg, så er der en fantastisk mulighed her.
    • Øvrige
    • Greve
    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 i Søborg over tid

Dato Alle jobs som øvrige
19. september 2024 56
18. september 2024 55
17. september 2024 58
16. september 2024 57
15. september 2024 60
14. september 2024 60
13. september 2024 60
12. september 2024 56
11. september 2024 57
10. september 2024 57
9. september 2024 56
8. september 2024 56
7. september 2024 56
6. september 2024 58
5. september 2024 60
4. september 2024 61
3. september 2024 57
2. september 2024 59
1. september 2024 64
31. august 2024 71
30. august 2024 76
29. august 2024 77
28. august 2024 77
27. august 2024 76
26. august 2024 68
25. august 2024 70
24. august 2024 70
23. august 2024 68
22. august 2024 68
21. august 2024 66
20. august 2024 65
Fold ud

Populære søgninger

Lignende søgeresultater

Se alle populære søgninger